Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The decision means layoffs for 53 of the New Hope, Minn., site’s 85 workers; the remaining 32 employees will either move to roles at BD’s Tempe, Ariz., location […]
Cardiovascular
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors BioFreedom stent
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
Study: No difference between Biotronik, Medtronic or Boston Scientific stents
A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]
FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]
Medtronic updates on corrected safety analysis for paclitaxel-coated balloon
Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]
