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Spectranetics

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

Veryan’s helical stent meets safety, efficacy endpoints after 12 months

February 9, 2018 By Sarah Faulkner

Veryan Biomimics

Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD. The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents. The probability of maintaining primary patency after 12 months was […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Vascular, Wall Street Beat Tagged With: C.R. Bard, cook medical, Medtronic, Spectranetics, veryan

These 10 medtech companies care a lot about research

November 29, 2017 By Chris Newmarker

Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced? Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Research & Development Tagged With: abiomed, Big 100, biomerieux, DexCom Inc., Insulet, Royal Philips, Spectranetics

Spectranetics wins FDA nod for Stellarex DCB

July 27, 2017 By Sarah Faulkner

Spectranetics

Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval. The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries. “The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Spectranetics

Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year

November 2, 2016 By Sarah Faulkner

Spectranetics

The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the 2016 Transcatheter Cardiovascular Therapeutics Symposium. The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured Tagged With: Spectranetics, TCT 2016

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