By Sarah Faulkner & Fink Densford Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. All of the study’s 13 subjects met the acute success measures of safety at […]
Vascular
Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions
Boston Scientific (NYSE:BSX) touted one-year data today from an analysis of its Eluvia drug-eluting vascular stent system, showing that the device is safe and effective in patients with long, complex, calcified lesions. The data were presented by Boston Scientific at the annual Vascular Interventional Advances meeting. The company’s Imperial trial included a 50-patient, single-arm analysis of Eluvia […]
Medtronic touts five-year data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) today touted five-year data for its In.Pact Admiral drug-coated balloon, highlighting the durability and efficacy of its device in people with peripheral artery disease in the superficial femoral and popliteal arteries. The company presented five-year results from its pivotal In.Pact SFA trial at the 2018 Vascular Interventional Advances conference. “Since the entrance of DCBs […]
Sales for Reva Medical up in Q3 following launch of bioresorbable scaffold
Shares in Reva Medical (ASX:RVA) rose today after the medical device maker posted its third-quarter financial results. The San Diego, Calif.-based company recorded a net loss of -$9 million on sales of $93,000 for the 3 months ended Sept. 30, for sales growth of 447% compared with the same period last year. Earnings per share were […]
FDA issues Class I recall for Roche Diagnostics’ warfarin test strips
The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices. Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The […]
Reva launches Fantom Encore bioresorbable scaffold
Reva Medical (ASX:RVA) said this week that it launched its Fantom Encore bioresorbable, drug-eluting scaffold and that the first person was treated in a post-market trial of the device. The Fantom Encore product is a third-gen coronary bioresorbable scaffold featuring a thin strut profile and Reva’s Tyrocore polymer. Reva noted that the device will be made […]
Boston Scientific CEO talks pricing pressure for drug-eluting stents
On an earnings call with analysts this week, Boston Scientific (NYSE:BSX) CEO Mike Mahoney touted the momentum of his company’s drug-eluting stent portfolio but noted that the technologies continue to face headwinds in the U.S. thanks to pricing pressure. The Mass.-based company reported third-quarter profits of $432 million, or 31¢ per share, on sales of $2.39 […]
Vascular Therapies raises $12m for drug-eluting vascular access implant
Vascular Therapies has raised $12.4 million from 29 investors as part of a $21.1 million round, according to a document filed last week with the SEC. The Cresskill, N.J.-based company is developing a sirolimus-eluting collagen implant for patients with end-stage renal disease. The bioresorbable drug-delivery system is designed to keep open a portal of entry […]
Cook Medical wins FDA nod for 5mm Zilver PTX stent
Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. “We spend a lot of time […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]