Drug-Eluting Balloon One Step Closer to FDA Submission as Medtronic Completes Enrollment for IN.PACT Study
Medtronic, Inc. (NYSE: MDT) announced today that its IN.PACT drug-eluting balloon clinical program had reached the enrollment needed to support submission to the FDA for approval to use this novel device in the treatment of peripheral disease, specifically blockages in the superficial femoral artery. Although the IN.PACT family of drug-eluting balloons (DEB) have been available in Europe for over four years, no drug-eluting balloons have been approved for use in the United States. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 4, 2013 Category: Cardiology Source Type: news
Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneurysm Repair
The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up. The data show 100 percent freedom from aneurysm-related mortality, 0 percent post-implant aneurysm rupture, 0 percent stent graft migration and 0 percent conversion to open repair for the 107 patients followed to three years. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 1, 2013 Category: Cardiology Source Type: news
New Medtronic Stent Graft and Sheath for AAA Repair Gets FDA Approval
Medtronic today announced FDA approval for the newest additions to its endovascular aortic aneurysm repair product line: the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the Sentrant Introducer Sheath. The company also announced that these devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery's "Vascular Annual Meeting 2013," which starts today May 30 and runs through the weekend at the Moscone Center in in San Francisco. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 30, 2013 Category: Cardiology Source Type: news
CE Mark Approval for Abbott's 48mm XIENCE Xpedition: World's Longest Drug-Eluting Stent
Abbott (NYSE: ABT) announced this week that it has gained European CE Mark approval for its 48mm XIENCE Xpedition everolimus-eluting coronary stent, making it the longest coronary stent currently available. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 26, 2013 Category: Cardiology Source Type: news
FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent
Today the U.S. Food and Drug Administration issued a Class I recall of the Zilver PTX Drug-Eluting Peripheral Stent. One month ago, Cook Medical, the device manufacturer, issued its own voluntary recall. It was not immediately clear as to why the FDA has now issued its own recall. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 25, 2013 Category: Cardiology Source Type: news
Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013
Volcano Corporation (NASDAQ: VOLC) today announced preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial during the hot line late breaking clinical trial session at EuroPCR 2013. These prospective results confirm prior retrospective publications, and demonstrate the clinical usefulness of an iFR ®/Fractional Flow Reserve (FFR) Hybrid approach to simplify lesion assessment and to save the use of hyperemic drugs in a significant number of patients. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 24, 2013 Category: Cardiology Source Type: news
Medtronic CoreValve® System Gains First Approval for Transcatheter Valve-In-Valve Procedures
Medtronic, Inc. (NYSE: MDT) today announced it has received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - May 24, 2013 Category: Cardiology Source Type: news