Philips Takes a Firm Stand in the DCB Market with ILLUMENATE
This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation."
Layout of the Land
C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Editor&...
Source: MDDI - November 13, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Medtronic's Valiant Navion Thoracic Stent Graft System Garners Both FDA and CE Mark Approvals
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 trea tment 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. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news
Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon.
The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia.
Get the full story at our sister site, Drug Delivery Business News.
The post Philips launches below-the-knee PAD trial for drug-coated balloon appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Featured Pharmaceuticals Vascular Wall Street Beat Royal Philips Source Type: news
5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA
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). (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - November 13, 2018 Category: Cardiology Source Type: news
Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich.
St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong.
“Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap of the co...
Source: Mass Device - November 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Catheters Distribution Cardiovascular Systems Inc. OrbusNeich Source Type: news
