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April 6, 2016
FDA OK to Medtronic's Micra: World's Smallest and 1st Transcatheter Pacemaker Approved in U.S.
Micra Pacemaker compared to a Nickel
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

April 3, 2016
Medtronic Announces Early Data and Completes Enrollment in CE Mark Cohort in Drug-Filled Stent Trial
Laser-drilled abluminal holes in Medtronic's Drug-Filled Stent
Medtronic plc (NYSE: MDT) announced new clinical data today from one of the endpoints in the RevElution Trial for its novel, next-generation Drug-Filled Stent (DFS). These new data showed rapid vessel healing without inflammation in Optical Coherence Tomography (OCT) data of the complete one-month follow-up patient cohort.


April 2, 2016
Medtronic CoreValve® System Demonstrates Superior Survival to Surgery in Aortic Stenosis Patients with Lower STS Scores
CoreValve in heart
The analysis of the sub-cohort compared 202 patients treated with the CoreValve System against 181 patients who received surgical aortic valve replacement (SAVR). The CoreValve TAVR patients demonstrated superior outcomes in all-cause mortality at two years compared to patients treated with surgical aortic valve replacement (15.0 percent vs. 26.3 percent; p=0.01). In addition, rates of combined all-cause mortality or major stroke were superior for TAVR with the CoreValve System (17.1 percent vs. 31.9 percent; p=0.0018).

April 1, 2016
Philips Volcano Announces More Than 5,000 Coronary Artery Disease Patients Enrolled in iFR Outcomes Trials
Dr. Patrick Serruys
Royal Philips (NYSE: PHG; AEX: PHIA) today announced that a combined total of more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using Philips Volcano’s proprietary iFR (instant wave-Free Ratio) pressure measurement technology versus conventional FFR (Fractional Flow Reserve) measurements.

March 31, 2016
First Patients Enrolled in Medtronic Trial in Low-Risk Aortic Stenosis Patients
CoreValve® Evolut® R Transcatheter Aortic Valve in Situ
Medtronic plc (NYSE: MDT) today announced that the first patients were enrolled in the expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States.


March 29, 2016
Societies Update Guidelines for Dual Antiplatelet Therapy
pills and a stent
The American College of Cardiology and the American Heart Association today released updated guidelines for dual antiplatelet therapy in patients with coronary artery disease. In general, duration of dual antiplatelet therapy recommendations in the document consist of a Class I recommendation of “should be given” for a minimum time period of time (usually six to 12 months).

March 21, 2016
Part One: FDA Panel Recommends Abbott's Absorb Bioresorbable Vascular Scaffold for Approval
Abbott's
This is the first installment of a two part feature regarding current thinking about the Bioresorbable Vascular Scaffold. Part One discusses the history and some general background issues surrounding the device; Part Two (to be posted later this week) consists of comments from leading interventional cardiologists about the current and future implications, predictions, critiques, and recommendations for the utilization of BVS.

March 16, 2016
Opsens Receives FDA 510(K) Clearance for the OptoWire II
Opsens FFR wire in blockage
This approval allows Opsens to market the OptoWire II in the world’s largest market. The OptoWire II is a new design comprising a hydrophilic coating that further improves the performances of the guidewire in different scenarios, such as in highly calcified and tortuous vessels.


March 15, 2016
Abbott's Absorb™, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee
Artist rendition of Abbott's Absorb BVS
Abbott (NYSE: ABT) announced today that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.


March 10, 2016
St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker
Nanostim™ leadless pacemaker, compared to a Euro
St. Jude Medical, Inc. (NYSE:STJ) today announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

March 7, 2016
Medtronic Begins CoreValve™ Evolut™ R "Real World" TAVR Study
CoreValve® Evolut® R Transcatheter Aortic Valve
Medtronic plc (NYSE: MDT) has announced the start of a new "real world" study of its CoreValve Evolut R transcatheter aortic valve. The first patients were enrolled at University Hospital in Bonn, Germany. The FORWARD study will enroll up to 1,000 patients at 60 centers worldwide.


March 6, 2016
Pete Nicholas to Retire as Boston Scientific Board Chairman
Pete M. Nicholas
Major medical device company Boston Scientific (NYSE:BSX) has announced that Pete Nicholas, its long-serving Chairman of the Board of Directors and co-founder, will formally retire from the Board in May. Founded almost four decades ago by Nicholas and John Abele, who met at their sons' soccer game in Massachusetts, Boston Scientific became one of the leading manufacturers of medical devices used in the interventional treatment of heart disease, stroke and more.

February 23, 2016
FDA Approves New CoreValve Low-Risk TAVR Study
CoreValve® Evolut® R Transcatheter Aortic Valve
Medtronic (NYSE: MDT) has announced FDA approval for a new study of transcatheter aortic valve replacement (TAVR). But this trial is different; this trial will be in patients at low-risk for the standard surgical procedure (SAVR). The device will be Medtronic's latest TAVR iteration, the CoreValve® Evolut® R, approved last June by the FDA, and will include 1,200 patients at up to 80 sites.

February 22, 2016
Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans
Medtronic Compia MRI™ Quad CRT-D SureScan®
Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available.

February 22, 2016
CE Mark for Boston Scientific's Eluvia Peripheral Stent
Eluvia™ Drug-Eluting Vascular Stent
Boston Scientific (NYSE: BSX) announced this morning that its Eluvia™ Drug-Eluting Vascular Stent has received the CE Mark for use in treating peripheral artery disease in the superficial femoral and proximal popliteal arteries. The company states that the Eluvia is the first polymer-based DES approved in Europe for use in the peripheral arteries.


February 18, 2016
Meta-Analysis Shows Medtronic's Solitaire™ Stent Retriever Device Improves Functional Outcomes for Acute Ischemic Stroke Patients; Reduced Mortality in Patients 80+
Medtronic's Solitaire™ stent retriever
A meta-analysis published online today in Stroke and presented at the International Stroke Conference (ISC) in Los Angeles, Calif., found that the addition of Medtronic plc's (NYSE: MDT) Solitaire™ stent retriever to current pharmaceutical treatment (IV-tPA) significantly improves functional outcomes in patients suffering stroke. The analysis also showed a significant reduction (20% vs. 40%, adjusted OR 3.7(1.3-10.6), p=0.01) in mortality for patients over the age of 80.

February 10, 2016
Study of Medtronic's Valiant TAAA (Thoracoabdominal Aortic Aneurysm) Stent Graft Begins
Medtronic’s Valiant TAAA Stent Graft
Medtronic plc (NYSE:MDT) has announced that the first patient has been treated with Medtronic’s Valiant TAAA, a new, minimally invasive stent graft system designed to treat thoracoabdominal aortic aneurysms (TAAA). The patient's treatment begins the physician-sponsored, investigational device exemption study (PSIDE) at Sanford Health in Sioux Falls, South Dakota.

February 10, 2016
"Alarming" Increase in Heart Attacks Among Young Adults in India Due to Smoking and Lifestyle
Logo of the Cardiological Society of India
"Stop Smoking!" is the heightened warning for young adults in India, based on a study presented today at the 67th Annual Conference of the Cardiological Society of India. The study looked at 310 patients who presented with acute coronary syndrome (ACS) during a two-year period to the Casualty (Emergency) Department of Sir Sunderlal Hospital. The frightening statistic is that the average age of these patients was 30 years old. The patients were almost all male, 90%, with the youngest ACS patient only 15 years of age.

February 9, 2016
New Real-World Comparison Showing Similar Efficacy Between the Lutonix® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016
Lutonix (L) and IN.PACT (R) Drug-Coated Balloons
Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.”

February 9, 2016
St. Jude Launches Mobile OCT/FFR/Angio System for Cath Labs in Europe and Japan
OPTIS Mobile Integrated Lab with OCT
St. Jude Medical (NYSE:STJ) recently announced that it has launched a mobile version of its OPTIS™ Integrated System in Japan and Europe. Like its built-in console cousin, the new system, dubbed OPTIS Mobile System, brings together optical coherence tomography (OCT), fractional flow reserve (FFR) and standard angiography.


February 5, 2016
FDA Nod to Medtronic MR-Conditional CRT-Defibrillators
Medtronic Compia MRI™ Quad CRT-D SureScan®
The U.S. FDA has cleared the first and only MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure: Medtronic's Amplia and Compia MRI™ Quad CRT-D SureScan® systems. This approval expands Medtronic’s portfolio to include a complete line of MR-conditional cardiac devices, including MR-conditional pacemakers, implantable cardiac defibrillators (ICDs), insertable cardiac monitors (ICMs) and now CRT-Ds.

February 4, 2016
40 Years Ago, There Was a Poster at the American Heart Association Meeting....
Gruentzig's 1976 AHA poster
(Commentary form the Editor's Blog) -- Today being TBT (Throw Back Thursday) on Twitter, Dr. Jordan Safirstein (@CardiacConsult) posted a photo this morning of a poster that appeared 40 years ago at the 1976 American Heart Association meeting. It’s a meaningful poster, since it was the first public presentation of the concept and initial studies of something called coronary angioplasty. Check out my video clip.

February 3, 2016
FDA OKs Expanded Patient Population for CoreValve
CoreValve (artist rendition)
Medtronic plc (NYSE:MDT) announced today that the FDA has revised the IFU (Instructions for Use) labeling for the CoreValve System to now include patients with end-stage renal disease and low flow, low gradient aortic stenosis. Previously, physicians were cautioned in the IFU against treating these patient populations with TAVR because of their severe comorbidities. The FDA's decision was based on positive data from the CoreValve U.S. Expanded Use Study.

February 1, 2016
CE Mark for 4.5 and 5.0mm Sizes of Medtronic Resolute Onyx Drug-Eluting Stent
Dr. David Hildick-Smith
Today the European regulatory agency, Conformité Européene, approved new sizes of Medtronic's drug-eluting stent, the Resolute Onyx™, in 4.5 and 5.0mm diameters. Additionally the device received the CE Mark for the treatment of the left main artery. Dr. David Hildick-Smith told Angioplasty.Org, "I think it is an excellent development that we will now have a DES which is ideally suited to the diameter of the Left Main. Previously we have had to take smaller stents and post-dilate them to the desired diameter and on occasions this might result in overstretching of the stent with loss of the ideal stent-to-artery ratio and drug concentration."

January 29, 2016
FDA Panel to Look At Data on Medtronic's Miniature Leadless Micra® Pacing System
Micra Pacemaker compared to a Nickel
Medtronic plc announced today that it will present data on its Micra® miniaturized leadless pacemaker to the FDA's Circulatory System Devices Panel on February 18. The Micra gained the CE Mark European approval in April and Medtronic has presented data in support of the Micra's safety and efficacy at several meetings, most recently at the American Heart Association meeting in November, with simultaneous publication of the results in the New England Journal of Medicine.

January 25, 2016
Patient Education About Aortic Stenosis? There's an App for That!
iPad with app
Medtronic, manufacturer of both surgical and percutaneous valves, has developed an easy-to-use iPad app, explaining the disease, its treatment options and, importantly, what happens after discharge from the hospital, when the level of care is reduced and additional support becomes very important. Dubbed the "Aortic Stenosis Patient Journey iPad App," nursing staff, as well as patients and their family, can download this tool from the iTunes store for free.

January 24, 2016
Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe
Svelte SLENDER stent (R) vs. standard DES (L)
New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year. The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach.

January 21, 2016
Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany
rof. Dr. Dierk Scheinert
University Hospital of Leipzig
Today Mercator MedSystems announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel. Prof. Dr. Dierk Scheinert commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."

January 15, 2016
Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve
Edwards SAPIEN 3 valve
Edwards today announced FDA approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.

January 11, 2016
Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease
patient on dialysis
Medtronic plc (NYSE:MDT) today announced that the IN.PACT® Admiral® drug eluting balloon has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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