Drug-eluting stents (or coated stents, or medicated stents) have been touted as solving one of the biggest problems of interventional coronary treatment: restenosis -- or reclosure of the artery. And the "Stent Wars" among the various manufacturers continue. Boston Scientific's TAXUS paclitaxel drug-eluting stent and the Johnson & Johnson/Cordis CYPHER sirolimus drug-eluting stent are now vying for U.S. market share with two newcomers, Medtronic's Endeavor, which was approved in February 2008 and Abbott's Xience, approved in July 2008. For more information, features and interviews, visit our Drug-Eluting Stent Center.

May 19, 2009
New Intravascular Ultrasound (IVUS) Study of Underexpanded Stents, Thrombosis and Restenosis
A study, published in the current issue of JACC Interventions, details 120 drug-eluting stent cases as viewed by intravascular ultrasound (IVUS) in order to examine characteristics that may lead to in-stent restenosis (ISR) or stent thrombosis. The researchers found that in cases of thrombosis, the proximal parts of many of the stents were inadequately expanded. An accompanying editorial suggests greater use of IVUS and more attention to detail can reduce the number of these adverse clinical events. (Read more...)

May 18, 2009
Medtronic to Participate in the Piper Jaffray Post-EuroPCR Summit
Medtronic, Inc. (NYSE: MDT) today announced it will participate in the Piper Jaffray PCR Post-Op Summit on Friday, May 22, 2009, in London. Scott R. Ward Scott Ward, President, CardioVascular Medtronic Scott Ward, president of the CardioVascular business and senior vice president at Medtronic, will speak to the attendees of the conference at 8 a.m. British Summer Time (2 a.m. Central Daylight Time). (Read more...)

May 16, 2009
Innovative Stent Manufacturer XTENT Plans To Close Business After Failing to Find Buyer
XTENT (Nasdaq: XTNT), maker of an innovative stent that received the European CE Mark just two months ago, is closing its doors after failing to find a partner or buyer, a goal first announced in January. The Company's Board of Directors voted yesterday that "it is in the best interests of the Company and its stockholders to liquidate the Company's assets and to dissolve the Company." The plan is subject to stockholder approval. (Read more...)

May 6, 2009
Heartburn Drugs Increase Cardiac Events for Stent Patients by 50%
Most stent patients are required to take the antiplatelet drug clopidogrel (Plavix) for at least a year to prevent blood clots inside the stent. A new study, presented today at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions, showed that the beneficial effects of Plavix are compromised by common drugs, used for the treatment of heartburn and ulcers: the combined risk of hospitalization for heart attack, stroke and other serious cardiovascular illnesses was increased by 50%. (Read more...)

May 4, 2009
Effectiveness in Stenting
As Volcano's CEO Scott Huennekens writes in an op-ed piece, there's a whole toolbox of devices and techniques that are candidates for "comparative effectiveness" in that they may be able to increase the success of interventional procedures -- or even target patients who need these procedures more accurately. (Read more...)

April 27, 2009
Medtronic Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic Stent Graft
Medtronic, Inc. (NYSE: MDT), today reported the start of THRIVE, the company's U.S. post-market clinical study of its Talent Thoracic Stent Graft for the endovascular repair of thoracic aortic aneurysms. (Read more...)

April 8, 2009
Medtronic's Endeavor Stent Reduces Occlusion of Small Arterial Side Branches by 50%
A new study, published online before print in Circulation: Cardiovascular Interventions, concludes that "Patients treated with ZES [Medtronic's Endeavor Zotarolimus Eluting Stent] were less likely to develop sidebranch occlusion during stent placement than patients treated with PES [Boston Scientific's Taxus Express Paclitaxel Eluting Stent]. (Read more...)

April 3, 2009
Medtronic Launches Driver Sprint RX Coronary Stent System Worldwide
Medtronic, Inc. (NYSE: MDT) announced earlier this week that it has begun the international launch of its Driver Sprint RX Coronary Stent System, which received the CE (Conformité Européene) Mark in February 2009. The company plans to have its bare-metal stent on a rapid exchange platform commercially available in more than 100 countries worldwide. “The Driver stent system has always been very deliverable,” explained leading stent researcher Dr. C. Dubois of Leuven University Hospital in Belgium. “Now, the new Driver Sprint system makes it even more deliverable for the most challenging anatomy.” (Read more...)

March 30, 2009
Medtronic's Endeavor® Drug-Eluting Coronary Stent Approved in Japan
Medtronic, Inc. (NYSE: MDT), today announced approval of its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare (MHLW), clearing the way for the highly anticipated launch of the product in the world’s second largest market for advanced medical technology. Medtronic plans to launch the Endeavor drug-eluting stent (DES) immediately following the authorization of reimbursement which is expected on May 1, making the Endeavor DES commercially available in every major market in the world. (Read more...)

March 29, 2009
Abbott's Market-Leading XIENCE V® Shows Increasing Clinical Advantages Over TAXUS® Express2™/TAXUS® Liberte™ Between Two and Three Years
Long-term data presented today from Abbott’s SPIRIT II clinical trial demonstrated that the clinical advantages of the XIENCE V® Everolimus Eluting Coronary Stent System continued to increase between two and three years compared to the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System / TAXUS® Liberte™ Paclitaxel-Eluting Coronary Stent System (TAXUS). (Read more...)

March 29, 2009
ZEST: 3 Stents Go Head-to-Head-to-Head
The results of ZEST, a large scale randomized multi-center trial of all comers were presented this morning to the i2 Summit at ACC.09 by Dr. Seung-Jung Park of Asan Medical Center in South Korea. The goal of the trial was to evaluate paclitaxel- and sirolimus-eluting stents compared with zotarolimus-eluting stents in patients with coronary artery disease. (Read more...)

March 29, 2009
Small Trial for Innovative 'Healing' Stent Contradicts Findings from Larger Studies
Cardiologists anticipating positive results from a small head-to-head study comparing the novel Genous 'pro-healing' stent to a third generation bare metal chromium-cobalt stent were disappointed yesterday by less than favorable data from the 100-patient GENIUS-STEMI study. The MACE rate was 24% for the Genous vs. 10% for the bare metal stent. TLR was 14% vs. 4%. Not only were these rates very high, but they were far different from data that has been presented in the initial clinical trials for the Genous, as well as a very large 5,000-patient observational study, called the e-Healing Registry. (Read more...)

March 28, 2009
Two-Year Data for Medtronic Drug-Eluting Stent Shows Continued Safety and Effectiveness
Two-year results for more than 2,000 patients in the international, E-Five study of Medtronic's Endeavor Zotarolimus-eluting Stent show that the stent was associated with a low rate of both overall (0.7 percent) and very late stent thrombosis (VLAST) at 0.1 percent. (Read more...)

March 28, 2009
Stents: Same Outcomes, Less Money Than Surgery for Many Heart Patients
For many patients with triple-vessel or left main disease, drug-eluting stents provide similar outcomes to bypass surgery -- and for less money, according to data from the SYNTAX trial, presented this morning to the i2 Summit at the American College of Cardiology's 58th annual scientific session. (Read more...)

March 27, 2009
Medtronic Announces ACC 2009 Presentations
Medtronic, Inc. (NYSE: MDT), today announced highlights of clinical data presentations scheduled for the 2009 American College of Cardiology (ACC) meeting that feature the company’s cardiovascular innovations, including the Endeavor Drug-Eluting Stent (DES) and the Export Aspiration Catheter. ACC.09 takes place in Orlando March 28–31 at the Orange County Convention Center. (Read more...)

March 26, 2009
Boston Scientific Announces ACC 2009 Schedule
Boston Scientific Corporation today announced the schedule of the Company's major events and news announcements at the 58th Annual Scientific Session of the American College of Cardiology / i2 Summit, which runs from March 28-31 in Orlando, Florida. (Read more...)

March 26, 2009
Cordis Celebrates 50 Years of Transforming Cardiovascular Care
As cardiologists are arriving in Orlando for the beginning of this weekend's 58th Annual Scientific Sessions of the American College of Cardiology, just a few hours away, Cordis Corporation will be celebrating its 50th anniversary as a manufacturer of innovative medical devices. (Read more...)

March 24, 2009
Is The Scaffolding Coming Down?
From the Editor's Blog -- Today's good news about Abbott's bioabsorbable stent brings the following analogy to mind: scaffolding. Unfortunately scaffolding inside the artery, unlike its building construction counterpart, cannot be removed once its job is done. (Read more...)

March 24, 2009
Abbott Moves Forward with Bioabsorbable Stent
Following recent publication of the two-year results of the ABSORB clinical trial of its novel bioabsorbable drug-eluting stent, Abbott Vascular today announced the start of the next phase of the trial, set to enroll 80 additional patients. Article contains an exclusive video of Dr. Charles Simonton, Chief Medical Officer for Abbott Vascular. (Read more...)

March 20, 2009
XTENT's Customizable Drug-Eluting Stent Gets European CE Mark Approval
Hopefully, for the innovative stent manufactured by XTENT, Inc. (Nasdaq: XTNT), yesterday's European approval has not come too late. On Thursday, the company announced that it has received CE Mark approval for its CUSTOM NX drug-eluting stent (DES) System. (Read more...)

February 17, 2009
Medtronic Reports Third Quarter Revenue of $3.5 Billion
The company reported third quarter revenue of $3.494 billion, a three percent increase over third quarter revenue reported in fiscal year 2008 or a six percent increase after adjusting for an unfavorable $110 million foreign exchange impact. (Read more...)

February 3, 2009
Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent
The PLATINUM clinical program will enroll 1,728 patients at 160 sites worldwide. The trial will compare the PROMUS™ Element™ Everolimus-Eluting Coronary Stent to the PROMUS Everolimus-Eluting Coronary Stent. The Company plans to develop additional variations of the Element Stent platform, including next generations of a bare-metal stent and a paclitaxel-eluting TAXUS® Element Stent. (Read more...)

January 28, 2009
Circulation Publishes Pivotal Two-Year Results On XIENCE V™ Drug Eluting Stent
Data published online today in Circulation from the SPIRIT III U.S. pivotal trial evaluating the XIENCE V™ Everolimus Eluting Coronary Stent System demonstrated that Abbott's market-leading XIENCE V outperforms the TAXUS® Express²™ Paclitaxel-Eluting Coronary Stent System (TAXUS) in reducing major adverse cardiac events (MACE) at two years. (Read more...)

January 28, 2009
TAXUS® Liberte® Drug-Eluting Stent System Approved in Japan
Japan has now approved its first second-generation drug-eluting stent, and that honor goes to Boston Scientific's TAXUS Liberte Paclitaxel-Eluting Coronary Stent System. The company announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the stent. (Read more...)

January 25, 2009
Medtronic Seeks Runners -- Stents Included
Medtronic (NYSE: MDT) recently announced that it is looking for runners from around the world who have benefited from medical technology to participate in the company's 4th Annual Medtronic Global Heroes program. Stent patients are included. The deadline for entry is March 31, 2009. (Read more...)

January 25, 2009
Study: CT Scans and Stents Successful in Treating Strokes
Emergency use of CT scans and stents may be able to treat and significantly reduce the symptoms of a stroke. That is the conclusion of a small 16-patient study presented this week by Dr. L. Nelson "Nick" Hopkins of the University at Buffalo, SUNY. The data, presented at the 21st Annual International Symposium on Endovascular Therapy (ISET), showed that stents were able to open blocked brain arteries in all of the patients, and that 11 patients (69 percent) had significant improvement in their stroke symptoms. (Read more...)

January 23, 2009
Economy Claims Innovative Xtent
In an announcement today, Xtent Inc. (NASDAQ: XTNT) located in Menlo Park, California, stated that it is engaging the services of an investment bank to help the company pursue strategic alternatives, possible sale of some or all of the company's assets, or other type of acquisition. And of it 121 employees, all but nine have received termination notices, effective March 23. (Read more...)

January 21, 2009
XIENCE V™ Stent Takes the Lead
In sharp contrast to the current gloomy picture in the healthcare sector, Abbott reported this morning that its 4th quarter 2008 global sales rose 10.1% over 2007, and that the company's XIENCE V drug-eluting stent was a significant contributor to the bottom line. (Read more...)

January 19, 2009
When Less is More: Stents, That Is
So many news reports about the recent FAME study in the New England Journal of Medicine drive home a message that is not exactly correct. The "Stents May Be Overused" headline is misleading. And here's why. (Read more...)

January 13, 2009
Dreadlines About Stents Revisited
How can a mere article in the "newspaper of record" be dangerous? Is the pen mightier than the catheter? Is there such a thing as a "killer journalist"? (Read more...)

October 23, 2008
Will Medtronic Get An Rx (Rapid Exchange) For Its Endeavor Stent?
Ending a prohibition that has lasted almost a decade, federal court judge D. Lowell Jensen of the Northern District of California ordered yesterday that the injunction preventing Medtronic's access to the Rapid Exchange (RX) delivery system will end on October 29, 2008. (Read more...)

October 22, 2008
ODESSA Trial Looks Inside Drug-Eluting Stents With Optical Coherence Tomography (OCT)
(Updated) The results of ODESSA showed that OCT could indeed accurately measure strut coverage and NIH. An interesting data point was confirmation of the differences in the currently available DES. ODESSA looked at Cypher, Taxus, Endeavor and Bare Metal stents. The results showed that at six months, virtually all the struts of the Endeavor stent were covered -- the healing was even more complete than with bare metal stents, which reinforces reports of little or no very late stent thrombosis with the Endeavor. At the same time, an inverse relationship was observed between strut coverage and growth of neo-intimal hyperplasia (NIH) -- the Endeavor had the highest NIH growth of the DES (also called Late Loss) while the Cypher stent had the least Late Loss, but the highest number of uncovered struts. (Read more...)

October 22, 2008
FDA Lifts Part of Boston Scientific's Warning Letter Restrictions
Boston Scientific announced today that the U.S. Food and Drug Administration has lifted part of the warning letter that the company has been laboring under for almost three years. (Read more...)

October 16, 2008
Danish Study Supports Efficacy of Endeavor® Stent
The target lesion revascularization (TLR) rate for the company's Endeavor® drug-eluting stent in the real-world Danish trial, SORT OUT III, was 4.0 percent. This result at nine months is consistent with the ENDEAVOR-Five real-world study, which reported an overall TLR of 4.5 percent at 12 months. The rates of myocardial infarction in the SORT OUT III study were very low for both the Endeavor (1.4 percent) and Cypher (0.5 percent) stents. Stent thrombosis rates were also consistent with earlier studies. Surprisingly, the SORT-OUT III study at nine months reported a 1.0 percent TLR rate for Cypher, considerably less than the 4.5 percent TLR reported in the similar SORT OUT II study, previously conducted in the same five centers by the same group. In addition, the stent thrombosis rate for the Cypher stent was 0.2 percent, compared to 1.7 percent reported in the SORT OUT II study. (Read more...)

October 15, 2008
HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS® Drug-Eluting Stents in Heart Attack Patients
One-year results showed comparable overall safety outcomes (death, stroke, myocardial infarction or stent thrombosis) between the two treatment groups (8.0 percent for the Express® bare-metal stent versus 8.1 percent for the TAXUS Express® Stent, p=0.92). There was a statistically significant 41 percent reduction in revascularization in the TAXUS Express group (7.5 percent for the Express Stent versus 4.5 percent for the TAXUS Express Stent, p=0.002). (Read more...)

October 14, 2008
Endeavor® vs. Taxus®: Medtronic's Drug-Eluting Coronary Stent Linked to Fewer Heart Attacks at Two Years Post Implant
In ENDEAVOR-IV, only one of the Endeavor patients (n=742) experienced a very late stent thrombosis (ARC definite/probable), compared to six of the Taxus patients (n=739): 0.1 percent vs. 0.8 percent (p=0.069). Very late stent thrombosis (VLST) is a rare but potentially fatal complication in which a blood clot forms around the stent a year or more after implant. VLST usually causes death or myocardial infarction (MI). (Read more...)

October 14, 2008
Sustained Safety Profile of Medtronic's Endeavor® Drug-Eluting Stent Differentiates It from Other DES
The latest update to an independently conducted pooled data analysis shows once again how the Endeavor drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT), is distinguished by persistently strong safety benefits for patients with coronary artery disease. Called ENDEAVOR-Safety, the analysis now includes more than 1,100 patients followed to four years. (Read more...)

October 13, 2008
New Data Shows Abbott's Bioabsorbable Drug Eluting Stent Is Absorbed Within Two Years -- Leaving Behind Functioning Blood Vessels
Abbott (NYSE: ABT) today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott's bioabsorbable drug eluting coronary stent and were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. (Read more...)

October 13, 2008
Abbott's XIENCE V™ Drug Eluting Stent Outperforms TAXUS® in Key Efficacy and Safety Endpoints Out to Two Years
Data from an independent meta-analysis of Abbott's (NYSE:ABT) SPIRIT II and SPIRIT III randomized clinical trials demonstrated that the XIENCE V™ Everolimus Eluting Coronary Stent System continues to deliver clinically significant benefits for patients compared to the TAXUS® paclitaxel-eluting coronary stent system out to two years. In this meta-analysis, which included patients from the United States, Europe and Asia-Pacific, XIENCE V demonstrated clinical superiority to TAXUS in the endpoints of target vessel failure (TVF) and major adverse cardiac events (MACE) at two years. (Read more...)

October 11, 2008
Boston Scientific Announces FDA Approval of Second-Generation TAXUS® Liberte® Drug-Eluting Stent
Boston Scientific Corporation (NYSE: BSX) today announced it has received approval from the U.S. Food and Drug Administration to market its second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System. The Company plans to launch the TAXUS Liberte stent early next month in the United States. The TAXUS Liberte stent was launched in Europe and other international markets in 2005. (Read more...)

September 25, 2008
Small-Size Drug-Eluting Stent Approved by FDA
When it comes to coronary artery blockages, the narrower the artery, the greater the chance that it will restenose (re-close) after placement of a stent. Drug-eluting stents (DES) are known to reduce restenosis, but the smallest diameter DES available in the United States has been a 2.5mm, stent; that is until today, when the U.S. Food and Drug Administration gave Boston Scientific Corporation (NYSE: BSX) approval to market its TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary Stent System for vessels as small as 2.25 mm in diameter. (Read more...)

July 30, 2008
Medtronic Stent Thrombosis Study Begins in U.S. Comparing Safety of Endeavor® and Cypher® Drug-Eluting Stents
The U.S. arm of the PROTECT Study is part of the largest randomized controlled trial of its kind. The PROTECT Study will enroll 8,800 patients with coronary artery disease to Evaluate differences in stent thrombosis and other endpoints. (Read more...)

July 10, 2008
Stent Safety Study of 5,000 Patients Started by Abbott for XIENCE V™ Drug Eluting Stent
Just one week after FDA approval of the XIENCE V™ Everolimus Eluting Coronary Stent System, Abbott has announced that six hospital centers already are recruiting and enrolling patients in the XIENCE V USA post-approval study. Post-marketing studies for stents are now required of companies by the FDA, as part of the approval process, in order to better monitor these devices. (Read more...)

July 8, 2008
Intravascular Ultrasound (IVUS) May Reduce Drug-Eluting Stent Thrombosis by a Third
A provocative study in the current issue of the European Heart Journal concludes that: "IVUS guidance during DES implantation has the potential to influence treatment strategy and reduce both DES thrombosis and the need for repeat revascularization." The results were striking, surprising even the investigators. At 12 months, definite stent thrombosis had occurred in 0.7% of the patients in whom intravascular ultrasound guidance had been utilized, but in patients where IVUS was not used, the stent thrombosis rate was 2.0%, almost three times higher. (Read more...)

July 2, 2008
Abbott's XIENCE™ V Everolimus Drug-Eluting Coronary Stent is Approved by FDA
Surprising analysts on Wall Street, who had recently written that Abbott's new drug-eluting stent might not be approved until the fourth quarter, Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. (Read more...)

June 28, 2008
Interview with Ron Waksman, MD, FACC
Our IVUS Center features a discussion about an important new study, just published in the European Heart Journal, showing that IVUS guidance can improve outcomes with drug-eluting stents, including significantly lower rates of stent thrombosis. (Read more...)

June 27, 2008
Half-Price Stents?
In a posting today, CNBC's Mike Huckman cites a research note that Boston Scientific is now bundling its TAXUS paclitaxel-eluting stent for $1,100 each -- less than half of its original price. (Read more...)

June 4, 2008
Paul LaViolette to Leave Boston Scientific
Boston Scientific announced yesterday that Chief Operating Officer Paul LaViolette, 50, will be retiring at the end of this month and his duties will be assumed by current President and CEO Jim Tobin, who will remain in his position "for the foreseeable future". The position of COO, held by LaViolette since 2005, will not be replaced. (includes video interview with Paul LaViolette.) (Read more...)

June 3, 2008
When Can I Stop Taking Plavix? -- A New Imaging Modality May Help Patients and Physicians Determine Optimal Duration of Antiplatelet Therapy in the Not-Too-Distant Future
(Updated) The question on the minds of a great many patients who have had a drug-eluting stent implanted is: "When can I stop taking Plavix? When will my drug-eluting stent be completely healed?" It's THE question of the day, and no one is really sure of the answer. However, a new imaging technology, called Optical Coherence Tomography or OCT, may help with this issue in the not-too-distant future.. (Read more...)

June 2, 2008
Abbott Looking for Japanese Approval of XIENCE™ V Everolimus Eluting Coronary Stent
Although Abbott's XIENCE V Everolimus Eluting Coronary Stent System is still awaiting U.S. FDA approval, the company already has submitted its application to Japan's Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA). The Japanese market is estimated at 200,000 stents implanted annually, the largest outside of the United States. (Read more...)

May 20, 2008
Medtronic's Endeavor™ Takes 20% of Drug-Eluting Stent Market in U.S.
President and CEO Bill Hawkins stated: "Physician acceptance is reflected in the market share that Endeavor gained in its first three months on the US market. We estimate Endeavor captured an average of 19% of the US market during the fourth 5/20/2008 4 quarter and exited the quarter above 20% market share." (Read more...)

May 19, 2008
New Smaller Size Embolic Protection Filter to Treat Narrower Bypass Grafts
Used in bypass surgery, the saphenous vein graft (SVG) is narrower than the internal mammary artery and tends to be more prone to re-blocking. When that occurs, angioplasty is often used to open it up again. One problem is that the plaque from a saphenous vein graft is also more "friable" and can flake off, which can have serious consequences. Today, Boston Scientific announced a smaller size filter, which will expand its use to even narrower vessels. (Read more...)

May 15, 2008
International Endeavor Registry Reports Safety and Performance of Medtronic Drug-Eluting Stent in Diverse Patient Population
New data presented today at EuroPCR reports extensive experience on the safety and performance of Medtronic's Endeavor Zotarolimus-Eluting Coronary Stent in routine clinical practice with a diverse patient population, providing in-practice alignment with results from the ENDEAVOR clinical trials. (Read more...)

May 15, 2008
"Life Wide Open": A Stent Cypher
Commentary from the Editor's Blog on the New England Journal critique of Johnson & Johnson's CYPHER stent TV ad campaign, such as it was. Was this really a Direct-To-Consumer effort? (Read more...)

May 15, 2008
Intravascular Ultrasound (IVUS) Use Growing with Integration into Routine Cath Lab Imaging
Intravascular Ultrasound, or IVUS, is an imaging technology that looks at arteries from the inside out. Invented two decades ago, IVUS recently has been gaining in usage due to safety concerns about stent thrombosis and proper stent placement during angioplasty. (Read more...)

May 13, 2008
Abbott Heart Stent Better at Keeping Coronary Arteries Open and Reducing Adverse Events: Part of a New Generation of "DES 2.0"
Two-year outcomes from the SPIRIT III trial, studying the XIENCE™ V Everolimus Eluting Coronary Stent System, were presented today at the EuroPCR 2008 meeting in Barcelona -- and the results showed Abbott's second generation stent to be superior to Boston Scientific's market-leading TAXUS paclitaxel-eluting stent in several important criteria. (Read more...)

May 13, 2008
Endeavor II Four-Year Results Demonstrate Long-Term Safety and Durable Efficacy of Medtronic Drug-Eluting Stent
Today at EuroPCR, Medtronic, Inc. (NYSE: MDT), released four-year data from the ENDEAVOR II clinical trial that reinforces the long-term safety and durable efficacy of the company’s Endeavor Zotarolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. (Read more...)

May 12, 2008
Medtronic Announces Start of International Study Comparing Endeavor® Resolute Drug-Eluting Stent to Abbott's Xience® V
Continuing its commitment to clinical excellence, Medtronic, Inc. (NYSE: MDT), today announced the start of an international study comparing the company’s Endeavor® Resolute Zotarolimus-Eluting Coronary Stent with Abbott Laboratory’s Xience® V Everolimus-Eluting Coronary Stent. The first implants in the study, called the RESOLUTE III All-Comers Trial, took place in Europe during the last two weeks. (Read more...)

April 22, 2008
Study in JAMA Shows Patients Treated With Abbott's XIENCE™ V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent
A study published in today's Journal of the American Medical Association (JAMA) demonstrated that use of Abbott's XIENCE™ V Everolimus Eluting Coronary Stent System in patients with coronary artery disease resulted in a significant 50 percent reduction in vessel renarrowing (in-segment late loss) at eight months, non-inferior rates of target vessel failure (TVF) at nine months, and an observed 42 percent reduction in major adverse cardiac events (MACE) at one year compared to the TAXUS® Paclitaxel-Eluting Coronary Stent System. (Read more...)

March 26, 2008
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
16 months after the FDA held hearings about safety issues with drug-eluting stents, the Agency has issued draft guidelines for future approvals. The guidelines include 12 months of initial data, with five years of follow-up. Today's draft guidance has a public comment period of 120 days. (Read more...)

March 19, 2008
Cook Medical Announces the Launch and First Patient Enrollment of the REFORM Clinical Trial
The FDA has approved initiation of the REFORM clinical trial, officials of Cook Medical announced today. The REFORM trial is designed to evaluate the Formula™ Balloon Expandable Stent for the treatment of renal artery stenosis, a narrowing of the renal artery that can result in hypertension, renal atrophy, and kidney failure if left untreated. (Read more...)

March 11, 2008
Abbott Receives CE Mark for Smaller-Size XIENCE™ V Drug Eluting Stent
Abbott announced today that it has received CE Mark (Conformité Européene) approval for a 2.25 mm version of its XIENCE™ V Everolimus Eluting Coronary Stent System, offering physicians a smaller stent based upon the proven efficacy, positive safety results and excellent deliverability of XIENCE V. (Read more...)

February 27, 2008
New "Y"-Shaped Stent Studied by Medtronic
Today Medtronic, Inc. announced the first human use of its new investigational bifurcation stent. The new stent employs an innovative Y-shaped design to match the anatomy of lesions that form at the junctions of coronary arteries. Dr. Robert Whitbourn, associate professor and director of the Cardiovascular Research Centre at St Vincent's Hospital in Melbourne, performed the first clinical implant of the new device on Feb. 25 as an investigator in the trial, dubbed the BRANCH study. (Read more...)

February 15, 2008
US judge increases damages against Boston Scientific in stent patent case; award totals $501M
(Mark Jewell, Associated Press)
A patent judgment against Boston Scientific Corp. has jumped to $501 million after a judge tacked on an additional $69 million in interest. U.S. District Judge John Ward ruled Thursday to expand the damages award -- decided by a federal jury in Marshall, Texas -- to cover interest on royalties dating to the medical device maker's 2004 U.S. launch of drug-coated heart stents. (Read more...)

February 13, 2008
Paclitaxel-Coated Balloon Keeps Leg Arteries Open
(Gene Emery, Reuters)
Balloons coated with a common cancer drug can help keep blood flowing in clogged leg arteries better than plain angioplasty balloons, German researchers reported Wednesday. These so-called drug eluting balloons have been seen as an alternative to drug-coated stents -- little mesh tubes often used to hold an artery open after angioplasty. (Read more...)

February 11, 2008
Boston Scientific Announces Major European Registry for Real-World Data on PROMUS, Endeavor and Cypher Drug-Eluting Stents
The PROENCY registry is the first to observe different 'Olimus'-eluting coronary stents. It will collect real-life clinical outcome data for Boston Scientific's PROMUS™ Everolimus-Eluting Coronary Stent and compare them with data from Johnson & Johnson's Cypher® Sirolimus-Eluting Stent and Medtronic's Endeavor® Zotarolimus-Eluting Stent in patients in routine clinical practice. (Read more...)

February 6, 2008
Thin-Strutted COBRA Stent Being Paired with Bioerodible Polymer for New Drug-Eluting Stent
CV Therapeutics, Inc. (Nasdaq: CVTX) and Medlogics Device Corporation announced today that the companies have entered into an agreement under which Medlogics has licensed CV Therapeutics' proprietary biopolymer stent coating technology to develop a drug eluting stent. (Read more...)

February 5, 2008
Stopping Plavix Doubles Risk of Heart Attack or Death for 90 Days, With or Without Stents
A study appearing in tomorrow's Journal of the American Medical Association (JAMA) reports a two-fold increase in death and heart attack in the 90 days after heart patients completed their prescribed course of medical therapy with clopidogrel (Plavix). The study suggests there may be a rebound effect with clopidogrel that may have major implications for acute coronary syndrome and stent patients. A study author also makes recommendations for what patients should do. (Read more...)

February 5, 2008
Boston Scientific posts $458M 4Q loss
Costs from Boston Scientific Corp.'s $27 billion acquisition of Guidant Corp. continue to erode the company's bottom line, but Boston Scientific sees signs of turnarounds in drug-eluting stent and pacemaker / defibrillator markets. (Read more...)

February 1, 2008
FDA Approves Medtronic's Drug-Eluting Stent
Following the unanimous recommendation of its advisory panel in October, the FDA today approved Medtronic's Endeavo® Zotarolimus Drug-Eluting Stent System, making it the third DES available in the U.S. and the first approval in almost four years (Read more...)

February 1, 2008
NICE Issues Final Guidance on Drug-Eluting Stents for the Treatment of Coronary Artery Disease
The draft guidance recommends the use of drug-eluting stents (DES) for those patients who are at higher risk of needing further stents if a conventional bare-metal stent (BMS) were used instead. These patients have a coronary artery less than 3mm in diameter, or the segment of the artery to be treated is longer than 15mm. The draft guidance also states that drug eluting stents should only be used if the price difference between it and a bare metal stent is no more than £300. (Read more...)

January 16, 2008
Terumo Receives CE Certificate for Nobori™ Drug-Eluting Stent
The Nobori™ stent system is a truly new generation drug eluting stent (DES) with a bioresorbable polymer, offering best in class clinical results, excellent deliverability and strong patient safety profile. The company intends to launch the product shortly and to expand to more than 20 countries during the first quarter of fiscal year 08. (Read more...)

November 29, 2007
Boston Scientific Welcomes FDA Panel Recommendation to Approve PROMUS™ / XIENCE™ V Everolimus-eluting Coronary Stent System
"Today's recommendation is a significant step toward making Boston Scientific's two-drug program a reality in the United States," said Hank Kucheman, Senior Vice President and President of Boston Scientific's Cardiovascular business. "Once approved in the United States, the PROMUS stent system -- together with our proven and market-leading TAXUS stent technology -- will enable Boston Scientific to offer physicians and their patients a choice of two distinct drugs, each on a highly deliverable stent platform." (Read more...)

November 29, 2007
FDA Advisory Panel Recommends Approval for Abbott's XIENCE™ V Drug Eluting Heart Stent
The FDA Circulatory System Devices Advisory Panel, which met today to hear data and opinions from the manufacturer, as well as outside experts, on the safety and efficacy of Abbott's XIENCE V Drug-Eluting Stent, has voted 9-to-1 to recommend approval. The FDA is not required to follow the Panel's recommendation, but usually does. This vote augurs the possibility of four drug-eluting stents on the U.S. market next year. (Read more...)

November 27, 2007
Abbott to Present Comprehensive Safety and Efficacy Data on XIENCE™ V Drug Eluting Stent to FDA Advisory Committee on November 29
"The data we have submitted to the FDA to support the approval of XIENCE V is robust, consistent across several independent randomized trials and shows sustained positive results over time," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "XIENCE V is the only drug eluting stent that has demonstrated clinical superiority over another drug eluting stent in a randomized clinical trial, and we look forward to sharing our data with the FDA Advisory Panel as they review this important new technology for physicians and patients." (Read more...)

November 12, 2007
About Those Stents: Tiny Time Bombs in Your Heart...or Not?
(The Editor's Blog)
Recent studies have reversed the conclusions of a year ago, regarding the safety of drug-eluting stents, according to an article in this morning's New York Times. So what has changed? (Read more...)

November 5, 2007
FDA Panel to Review Abbott's XIENCE™ V Drug-Eluting Stent
(Angioplasty.Org Feature)
Such a review for Abbott's stent has been a topic of speculation in the interventional cardiology community for some time, especially on the heels of the same Panel's review and unanimous recommendation last month of Medtronic's Endeavor® drug-eluting stent. (Read more...)

November 5, 2007
Abbott Confirms FDA Advisory Panel to Review XIENCE™ V Drug Eluting Stent on November 29
(Abbott Laboratories)
Abbott announced today that the U.S. Food and Drug Administration (FDA) has confirmed a Circulatory Systems Devices Advisory Panel meeting on November 29, 2007, to review the company's Premarket Approval (PMA) submission for the XIENCE™ V Everolimus Eluting Coronary Stent System. (Read more...)

November 2, 2007
Market For Drug-Eluting Stents Grows Crowded
(Peter Benesh, Investor's Business Daily)
The race is on among medical device makers to grab bigger pieces of a shrinking market for cardiovascular stents. The latest entrant is Medtronic, with Abbott Labs coming up fast on incumbents Boston Scientific and the Cordis unit of Johnson & Johnson. (Read more...)

October 10, 2007
FDA Advisory Committee Recommends Medtronic's Endeavor® Drug-Eluting Stent for Approval
The long-awaited review of Medtronic's entry into the U.S. drug-eluting stent market happened today and the Endeavor stent has received unanimous approval from the FDA Circulatory Devices Panel -- an approval usually followed by the FDA. This development augurs well for Medtronic to be the third drug-eluting stent, possibly by the end of the year. (Read more...)

September 4, 2007
International study shows risks from drug-coated stents in some heart attack patients
(source: Associated Press)
Some heart attack patients, those with elevated ST segments, would be better off if their doctors avoided using drug-coated stents to open their clogged arteries, an international study found, raising new concerns about the devices. The study, presented Tuesday, showed that heart attack patients who received drug-coated stents in an emergency situation were five times more likely to die after two years than those who received bare metal stents. (Read more...)

September 2, 2007
New research shows drug-coated stents may not significantly increase risk of blood clots
(source: AP)
Last year, research suggested that the devices were responsible for an increased number of fatal blood clots. But on Sunday, Dr. Stefan James of the Uppsala Clinical Research Centre in Sweden presented follow-up results from last year's study to the European Society of Cardiology conference, which runs until Wednesday in Vienna. (Read more...)

September 2, 2007
Swedish Registry States: Drug Eluting Stents Are Not Dangerous
New data about the safety of drug- eluting stents (DES) translates into excellent news for thousands of patients with cardiovascular disease, according to The Society for Cardiovascular Angiography and Interventions (SCAI). These new findings also underscore the crucial importance of training physicians in the proper selection of patients, proper implantation technique, and in prescribing a strict regimen of medications that prevent blood clots in the first one to two years after DES implantation. (Read more...)

September 2, 2007
Safety Profile of TAXUS® Liberte™ Stent System Highlighted in World's Largest Stent Registry
The one-year results demonstrated a low overall 3.9 percent rate of TAXUS Liberte stent related cardiac events, including cardiac death (1.1 percent), myocardial infarction (0.9 percent), and TAXUS Liberte stent related re-intervention of the target vessel (2.5 percent). The one-year stent thrombosis rate was 0.8 percent, which is consistent with safety data from other DES registries. (Read more...)

August 27, 2007
British doctors protest new heart stent proposal
(source: Associated Press)
British heart doctors are trying to defeat a proposal to end government coverage of drug-coated heart stents, tiny metal-mesh tubes that prop open clogged arteries. The proposal was made by Britain's National Institute for Health and Clinical Excellence, which has the lead role in deciding what the country's health system pays for. (Read more...)

July 19, 2007
Abbott Enrolls First Patient in World's First Clinical Trial Designed to Study Drug Eluting Stent Treatment in Women
Abbott today announced that the first patient was enrolled in its XIENCE V SPIRIT WOMEN clinical trial, the world's first clinical trial designed to study the safety and effectiveness of drug eluting stent treatment in women. Liliana Grinfeld, M.D., of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure. (Read more...)

July 19, 2007
Boston Scientific Announces First Implant of TAXUS® Element™ Platinum Chromium Stent
The TAXUS Element Stent features the proprietary Platinum Chromium Alloy, designed specifically for stents. This alloy, coupled with an innovative new stent design, is designed to enable thinner struts, increased flexibility, and a lower profile while improving radial strength, recoil, and radiopacity. (Read more...)

July 2, 2007
Medtronic ENDEAVOR IV Drug-Eluting Stent Clinical Trial Meets Primary Endpoint
Medtronic announced today that results from its Endeavor IV clinical trial showed that its new drug-eluting stent achieved its endpoint of non-inferiority with Boston Scientific's Taxus stent. The study of over 1,500 patients will become part of the data on over 4,100 patients worldwide that will be submitted to the FDA in the fall as the basis for approval of the Endeavor in the U.S. (Read more...)

June 15, 2007
Cordis Resolves FDA CYPHER Stent Warning Letter
The lifting of the warning letter means that Cordis is now free to seek expanded indications for the CYPHER stent, and to submit next generation devices for approval. Currently, the company markets a "more deliverable" version of the CYPHER in Europe. (Read more...)

June 8, 2007
Consumer Reports Gives Incorrect Information About Angioplasty and CT Angiograms
Last week Consumer Reports posted their recommendations on angioplasty and CT angiograms, as part of their CR Medical Guide web site. The article is riddled with incorrect information and assumptions and leaves one with the impression that coronary artery disease is best treated with medications alone, or bypass surgery. (Read more...)

June 1, 2007
Abbott XIENCE™ Drug-Eluting Stent Submitted for FDA Approval
Abbott has completed its FDA application and is hoping for a first quarter 2008 approval for the drug-eluting stent it acquired from Guidant. The application also includes a request for approval of a private-label version, called PROMUS, to be marketed by Boston Scientific. (Read more...)

May 30, 2007
Most Heart Stents Are Placed Imperfectly, Increasing Risk of Heart Attack or Reclosure
Results of a new study show that stent placement involves a "geographic miss" two-thirds of the time, resulting in a three-fold increased risk of heart attack and a two-fold increase in reintervention. The article includes interviews with Dr. Marco Costa of the University of Florida College of Medicine in Jacksonville, chief investigator for the S.T.L.L.R. study, and Dr. Antonio Colombo of Columbus and San Raffaele Hospitals in Milan, Italy (Read more...)

May 22, 2007
No Late Stent Thrombosis for Medtronic Endeavor Drug-Eluting Stent
Medtronic presented new three and four year data from the ENDEAVOR clinical trial program reinforcing the existing safety and efficacy profile of the Endeavor® drug-eluting coronary stent system, showing sustained safety, significant reductions in repeat procedures and no late stent thrombosis in either trial using the pre-specified trial protocol definitions adjudicated by the Harvard Clinical Research Institute. Using the broader Academic Research Consortium (ARC) definitions for definite and probable stent thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III trials was still very low: 0.5% at three years while the Driver bare metal stent had a rate of 1.5%. (Read more...)

May 22, 2007
Medtronic's Next Generation Endeavor® Resolute Drug-Eluting Stent Shows Positive Nine-Month Results at EuroPCR
Medtronic's next generation Resolute drug-eluting stent showed good results for restenosis with a low number of adverse cardiac events and no protocol-defined stent thrombosis in a patient population with more complex blockages and with the use of longer stents. (Read more...)

May 21, 2007
Medtronic Announces Start of 8,800-Patient Clinical Trial Evaluating Drug-Eluting Stent Safety
The 8,800-patient trial, called PROTECT (Patient Related OuTcomes with Endeavor versus Cypher stenting Trial), will compare the Medtronic Endeavor(R) zotarolimus-eluting coronary stent system and the Johnson & Johnson Cypher(R) sirolimus-eluting stent, using key safety endpoints and other clinically relevant outcomes. (Read more...)

May 8, 2007
Boston Scientific Announces Japanese Launch of TAXUS® Express2™ Coronary Stent System
Boston Scientific Corporation today announced the launch of its TAXUS® Express2™ paclitaxel-eluting coronary stent system in Japan. The product was approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) on March 30; reimbursement has now been granted by the National Health Insurance System, effective May 1. (Read more...)

May 7, 2007
Conor Medsystems, LLC Reports COSTAR II Pivotal Drug-Eluting Stent Trial Conclusions
The Conor COSTAR II trial has failed to prove non-inferiority of the CoStar stent to Boston Scientific's Taxus. Johnson & Johnson, which acquired Conor in January for $1.4 billion, will terminate existing clinical trials and work with its marketing partners to cease sales in the countries where the Conor stent is currently approved for sale. (Read more...)

April 7, 2007
Don't Cancel Your Angioplasty or Heart Stent Yet, Say Patient Advocates
The real take away from the COURAGE trial, is not just that medication is useful, which we know, but that patients benefit from substantial compliance education and lifestyle support. Patients need to participate in treatment decisions, so that they understand their treatment options and can commit to a course of action. (Read more...)

March 28, 2007
Answers to Top Ten Questions About Stents and Angioplasty vs. Drug Therapy: COURAGE Trial Results Breed Public Confusion
The highly-anticipated results of a study comparing heart stents and angioplasty to drug treatment that were released Tuesday have set off a media firestorm of misinterpretation, causing confusion for patients and physicians. (Read more...)

March 27, 2007
The Goal of Therapy in Patients With Chronic Stable Angina Is the Relief of Symptoms
Results of the COURAGE trial, presented today at the American College of Cardiology Annual Scientific Session, are unlikely to alter the approach that interventional cardiologists take in treating most patients with chronic stable angina, say leaders from the Society for Cardiovascular Angiography and Interventions (SCAI), the leading professional society for interventional cardiologists in the United States. (Read more...)

March 23, 2007
Boston Scientific Announces Industry-Leading Program to Improve Anti-Platelet Compliance for DES Patients
The company today announced a program designed to improve patient compliance with physician-prescribed anti-platelet therapy following implantation of a drug-eluting stent (DES). This program is the first of its kind in the medical device industry and is expected to launch in the United States later this year. It will be made available to all patients who receive a DES, regardless of brand, through their prescribing physician. (Read more...)

March 5, 2007
Waxman's Congressional Committee Requests Clinical and Marketing Information About Drug-Eluting Stents from Boston Scientific and Cordis
Although both stent companies had been asked by the FDA to present clinical data about drug-eluting stents and late stent thrombosis at the December panel meeting, this is the first time that an official body has requested marketing information. (Read more...)

February 23, 2007
Second Generation Conor CoStar Drug-Eluting Stent Data to be Announced at EuroPCR
Stent Wars will continue at the EuroPCR course in late May when Conor Medsystems, now part of Johnson & Johnson, presents results from it pivotal COSTAR II clinical trial. (Read more...)

February 6, 2007
Medicare Responds to Wall Street Journal Article about Restrictions on Drug-Eluting Stents
This morning's Wall Street Journal reports that Medicare is considering restricting reimbiursement for drug-eluting stents. Medicare's response to Angioplasty.Org was that the Wall Street Journal "misunderstood whomever they were talking to." (Read more...)

January 31, 2007
Johnson & Johnson Completes Acquisition of Conor Medsystems
Johnson & Johnson announced it completed its acquisition of Conor Medsystems, Inc. and Conor's second generation drug-eluting stent technology on the same day that rival Boston Scientific announced a significant drop in sales of its Taxus drug-eluting stent. Johnson & Johnson had reported a similar drop in sales for its Cypher stent last month. (Read more...)

January 31, 2007
Conor Medsystems Stockholders Approve Merger Agreement with Johnson & Johnson
(source: Conor Medsystems)
Conor Medsystems, Inc. today announced that its stockholders approved the merger agreement between Conor Medsystems, Johnson & Johnson and a wholly owned subsidiary of Johnson & Johnson. The proposed transaction is expected to close within the next few days, subject to the satisfaction of the remaining closing conditions. (Read more...)

January 31, 2007
Encouraging Results for First International Trial of Drug-Eluting Stent in Legs
(source: Cook Medical)
Cook Medical's Zilver PTX Paclitaxel-Eluting Stent (DES) trial results demonstrated no stent fractures. The major adverse event (MAE) rate was equivalent to conventional balloon angioplasty treatment at its six-month follow-up point, as reported by the trial's national principal investigator today. Michael Dake, M.D., national principal investigator for Cook's Zilver® PTX Drug-Eluting Stent Trial, presented important nine-month data on the first 60 patients in the randomized trial examining the safety of using Cook's Zilver PTX stent to treat blockages of the superficial femoral artery (SFA) above the knee. (Read more...)

January 29, 2007
New Advisory: Will Stent Patients and Their Doctors Get the Message?
Burt Cohen, patient advocate and Editor-in-Chief of Angioplasty.Org, applauds the groups for publicizing these issues. However, he adds: "It's admirable and important for these societies to band together and put out this Advisory. But there's a disconnect between what these advisories recommend and what patients experience." (Read more...)

January 18, 2007
FDA Approves 18-Month Shelf Life for TAXUS® Stent System
(source: Boston Scientific Corporation)
The U.S. Food and Drug Administration (FDA) has approved extending the shelf life of Boston Scientific's TAXUS® Express(2)™ paclitaxel-eluting coronary stent system in the United States to 18 months from the current shelf life of 12 months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS Stent -- in particular the drug content, drug degradation profile and drug-release -- was maintained within FDA-approved specifications at 18 months. The newly approved TAXUS Stent U.S. shelf life is longer than any competing drug-eluting stent product.

January 11, 2007
SCAI Issues Clinical Alert on Drug-Eluting Stents and Late Thrombosis
(source: Society for Cardiovascular Angiography and Interventions)
Following the FDA Panel held on December 7-8, the SCAI has issued what it terms "Practical Advice to Physicians on the Use of Drug-Eluting Coronary Artery Stents".

January 11, 2007
Private-Label Version of Abbott's XIENCE™V Drug-Eluting Coronary Stent System Launches in Europe
(source: Abbott)
A private-label version of Abbott's XIENCE™ V Everolimus Eluting Coronary Stent System has launched in Europe, Boston Scientific Corporation announced today. The PROMUS™ Everolimus-Eluting Coronary Stent System is designed, studied and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies announced last year.