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 […]
Spectranetics
Veryan’s helical stent meets safety, efficacy endpoints after 12 months
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 […]
These 10 medtech companies care a lot about research
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 […]
Spectranetics wins FDA nod for Stellarex DCB
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 […]
Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year
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, […]
