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April 24, 2019
Bringing Japanese Know-How to the Global Market: A Visit to Shimadzu Medical Systems
Shimadzu Trinias Angiography System
TCROSS NEWS and its global partner, Angioplasty.Org, visited Shimadzu Corporation, a major Japanese company founded in 1875, to learn about its plans for future overseas business development of its angiography systems. We saw demonstrations of the Trinias Angiography System, the SCORE StentView software and more.

February 26, 2019
FDA Approves Medtronic's Resolute Drug-Eluting Stent Platform for Treatment of Chronic Total Occlusions
Medtronic's Resolute Onyx Drug-Eluting Stent
The FDA today approved an expanded indication for Medtronic's family of Resolute zotarolimus-eluting coronary stents: use in the treatment of de novo chronic total occlusions (CTO). This approval includes all Resolute DES devices, including the Resolute Onyx™ and Resolute Integrity™ DES.

January 30, 2019
Medtronic Valiant™ Captivia™ Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients
Valiant™ Captivia™ Thoracic Stent Graft
Medtronic plc (NYSE:MDT) announced new data supporting the long-term durability, safety, and efficacy of the Valiant™ Captivia™ thoracic stent graft system for the treatment of blunt thoracic aortic injury (BTAI). The presentation by Himanshu J. Patel, M.D., University of Michigan Department of Cardiac Surgery at The Society of Thoracic Surgeons Annual Meeting, was the first and only five-year industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).

January 17, 2019

Philips Launches Azurion with FlexArm to Set New Standard for the Future of Image-Guided Procedures
Azurion with FlexArm
During increasingly complex interventions, clinicians need to quickly and easily visualize critical anatomy and identify changes to the patient during the procedure. Azurion with FlexArm includes a set of innovations that makes it easier for the clinician to perform imaging across the whole patient in both 2D and 3D. As the clinician moves the system, the image beam automatically maintains alignment with the patient, allowing more consistent visualization and enabling them to keep their focus on the treatment.

January 15, 2019
Medtronic Launches Mobile App That Communicates Directly with World's First Smartphone-Connected Pacemakers
MyCareLink Heart™
mobile app
Compatible with Medtronic BlueSync™ technology-enabled pacemakers, the MyCareLink Heart mobile app is designed to securely and wirelessly send device data to the Medtronic CareLink™ network via smart technology, eliminating the need for a dedicated bedside monitor or other remote monitoring hardware.

December 11, 2018
Shockwave Announces Collaboration with Abiomed on Physician Training
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and the two companies will collaborate on a training and education program in the United States and Germany focused on the benefits of complementary use of their respective technologies.

November 13, 2018
Medtronic's Valiant Navion Thoracic Stent Graft System Garners Both FDA and CE Mark Approvals
Valiant Navion Thoracic Stent Graft System
Only three weeks ago, Medtronic's Valiant Navion™ Thoracic Stent Graft System received FDA approval. Today, the company announced that its low profile device now has been approved for the CE Mark in Europe as well. According to Medtronic, this lower profile stent graft, which was eight years in the making, now makes it possible to use as a treatment in the broadest possible patient population, especially in those whose anatomy would not permit thoracic endovascular aneurysm repair (TEVAR), such as patients with narrower or more curved iliac arteries, most commonly female.

November 12, 2018
5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
IN.PACT Admiral Drug Coated Balloon (DCB)
At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD).

October 23, 2018
Medtronic Receives FDA Approval for Valiant Navion™ Thoracic Stent Graft System
Valiant Navion Thoracic Stent Graft System
Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion™ thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).

October 8, 2018
Drug-Eluting Stent Expansion Chart
stent expansion chart
A useful chart for the cath lab wall, this chart, created by Dr. Ajay Kirtane and the teams at NY Presbyterian/University of Columbia Medical Center, shows the nominal and post-dilatation expansion limits for four widely-used drug-eluting stents: Synergy (Boston Scientific), Resolute Onyx (Medtronic), Xience Sierra (Abbott Vascular), and EluNIR (Medinol/Cordis).

October 2, 2018
New Data for IN.PACT Drug-Coated Balloon Show Sizable Advantage Over Standard PTA in Peripherals
Dual presentations, made a little over a week ago at the Transcatheter Cardiovascular Therapeutics (TCT) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meetings in San Diego and Lisbon, showed significant superiority of Medtronic's IN.PACT Admiral drug-coated balloon (DCB) over standard Percutaneous Transluminal Angioplasty (PTA)

September 24, 2018

Medtronic Builds on TAVR Clinical Evidence Portfolio with Five-Year CoreValve Durability Data and Complete Two-Year Outcomes in Intermediate Risk Aortic Stenosis Patients
Medtronic's CoreValve Evolut
Medtronic (NYSE:MDT) announced new data presented at the 30th TCT conference in San Diego. Investigators presented the longest-term data to-date from the CoreValve U.S. Pivotal Trial, in addition to the complete two-year outcomes from the SURTAVI trial, which confirmed the excellent outcomes previously predicted in aortic stenosis patients at intermediate surgical risk.

August 15, 2018
Medtronic Announces Commercial Launch of the IN.PACT™ Admiral™ Drug-Coated Balloon in Japan
IN.PACT™ Admiral™ Drug-Coated Balloon
Medtronic plc (NYSE:MDT) today announced full commercial launch of the IN.PACT™ Admiral™ Drug-Coated Balloon (DCB) in Japan. The news follows the completion of a post-market clinical trial, which enrolled 300 subjects. IN.PACT Admiral received approval last year from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries). The MHLW also granted reimbursement approval for the IN.PACT Admiral in December of 2017.

June 23, 2018
FDA OKs IN.PACT™ Admiral™ Drug Coated Balloons of 200mm and 250mm Lengths
IN.PACT™ Admiral™ Drug-Coated Balloon
A subset of Medtronic's IN.PACT Global Study analyzed very long lesions in the SFA of over 180mm (7 inches), including cases of in-stent restenosis (ISR) and chronic total occlusions (CTO). The one-year results showed patency of 89.1% and clinically-driven target lesion revascularization at 7.1%. As a result of these findings, in April the FDA approved the IN.PACT DCB for treatment of long lesions. And last week, the FDA approved two new long length IN.PACT balloons (200mm and 250mm) that will become an important part of the armamentarium, implementing the April long lesion approval.

May 23, 2018
Newest Generation of Leading Heart Stent is Now Approved in the U.S. for People with Coronary Artery Disease
Xience Sierra Everolimus-Eluting Stent
Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of XIENCE include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.

May 21, 2018

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
Shockwave Medical’s Intravascular Lithotripsy System
Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced the European commercial availability of Intravascular Lithotripsy (IVL) for calcified coronary artery disease (CAD), as well as the enrollment of the first patient in the DISRUPT CAD II post-market study by Professor Jonathan Hill, MD, at King’s College in London.

May 24, 2018
Signal of Early Healing of Drug-Eluting Stent Seen in Resolute Onyx 1-Month OCT Study
To test how completely and quickly an artery implanted with a Resolute Onyx healed, a small group of 15 patients had OCT imaging performed at one month (13 of them diagnosed with acute coronary syndrome or ACS). The results were presented this week at the annual EuroPCR meeting in Paris. At only one month, an average of 88% of the struts were covered by neointimal formation (new cell growth over the struts) with 92.3% of the total stented area showing complete coverage.

April 23, 2018
Medtronic IN.PACT™ Admiral™ Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions
IN.PACT™ Admiral™ Drug-Coated Balloon
Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT™ Admiral™ Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, showing a one-year patency rate of 89.1% and a clinically-driven target revascularization (CD-TLR) rate of 7.1%.

April 5, 2018
Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics
Medtronic plc (NYSE: MDT) today announced Laura Mauri, M.D., M.Sc., interventional cardiologist and clinical researcher at the Brigham and Women's Hospital, and professor of medicine at Harvard Medical School, will join Medtronic as Vice President, Global Clinical Research & Analytics. Dr. Mauri will direct the company's dynamic global clinical research strategies which leverage her widely recognized clinical trial leadership and deep domain expertise in medical technology evaluation and clinical research methodology.

February 26, 2018
Medtronic's Resolute Onyx Stent Now Available in Diameters from 2.0-5.0mm
Medtronic Resolute Onyx
Based primarily on the results of the RESOLUTE ONYX 2.0 mm Clinical Study, first presented at the EuroPCR meeting in May 2017, the U.S. FDA has approved Medtronic's Resolute Onyx™ 2.0mm zotarolimus-eluting stent, making it the smallest diameter DES on the market. The news, announced today by Medtronic plc (NYSE: MDT) means that the Resolute Onyx line is now available in the widest range of any coronary stent, from 2.0mm to 5.0mm

January 30, 2018
IN.PACT Admiral Demonstrates Consistent and Durable Outcomes in New Two-Year Japan Data and IN.PACT Global Critical Limb Ischemia Cohort Analysis
The new data presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany, included the two-year results from the MDT-2113 study (IN.PACT SFA Japan) and data from a critical limb ischemia (CLI) subgroup analysis from the IN.PACT Global Study.


January 26, 2018
Medtronic Launches IDE Study to Evaluate the Abre™ Venous Self-Expanding Stent System in Patients with Deep Venous Disease
Dr. Erin Murphy

The multi-center, single arm study intends to enroll 200 subjects with deep venous disease. The primary efficacy endpoint will evaluate patency at 12 months and the primary safety endpoint will evaluate the incidence of composite Major Adverse Events (MAE) at 30 days following stenting of an obstruction in the iliofemoral venous segment. Data from the study will be used to support the Abre stent U.S. pre-market approval (PMA) application for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

January 24, 2018
Medtronic Launches ENCHANT Study to Evaluate ChEVAR Parallel Graft Technique with the Endurant™ II/IIs Stent Graft System
Endurant IIs Stent Graft
A ChEVAR procedure refers to the use of a parallel graft chimney technique that uses covered renal stents with a standard aortic stent graft. The study is the first to assess the clinical outcomes, safety, and performance of the ChEVAR technique for treating patients with complex aneurysms with short infrarenal neck lengths of >2 mm in a real-world setting with the Endurant™ II/IIs Stent Graft System.

January 10, 2018
3-Year Outcomes of Surgical vs. Endovascular Revascularization for Critical Limb Ischemia
Dr. Osama Iida discusses the SPINACH Study, recently published in Circulation: Cardiovascular Interventions. This registry randomized 548 patients and, while showing no significant differences in the endpoint, the study did indicate that certain patient populations do better with one or the other of these revascularization strategies. (Posted in collaboration with TCROSS NEWS)

January 8, 2018
Study: Similar Outcomes for 6 vs. 12 Months of DAPT for STEMI Patients Treated with Medtronic's Resolute Integrity Drug-Eluting Stent

One year is the recommended DAPT duration for STEMI patients after stenting. But this new study shows that 6 months may be adequate with certain devices: important data, especially for patient at high risk for bleeding.

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