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 […]
Vascular
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 […]
Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]
Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Roughly 17 million people in the U.S. […]
Medtronic launches In.Pact Admiral drug-coated balloon in Japan
Medtech titan Medtronic (NYSE:MDT) said today that it launched its In.Pact Admiral drug-coated balloon in Japan. The company won approval and reimbursement for its device last year from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg. Approval for Medtronic’s In.Pact Admiral system in Japan was […]
Reva wins CE Mark for bioresorbable scaffold in below-the-knee PAD
Reva Medical (ASX:RVA) said yesterday it won CE Mark approval in the European Union for its Motiv bioresorbable drug-eluting scaffold, now cleared for treatment of below-the-knee peripheral artery disease. The San Diego-based company’s Motiv is made from the company’s proprietary radiopaque Tyrocore polymer designed for vascular scaffolds. Reva said that over the coming months, it will […]
United Therapeutics $216m deal for SteadyMed clears HRS Act waiting period
United Therapeutics (NSDQ:UTHR) said today that it stepped closer to completing its $216 million acquisition of SteadyMed (NSDQ:STDY) after terminating the the HSR Act waiting period. The merger combines two companies that were in court as recently as last November, fighting over patents covering treprostinil, the active ingredient in both companies’ lead products. In the deal, United Therapeutics will pay […]
Cook Medical touts launch, first use of Advance CS, Compass CT systems
Cook Medical today announced the launch and first use of its Advance CS coronary sinus infusion catheter and Compass CT disposable pressure transducer designed for treating heart failure patients. The CS catheter is a percutaneous balloon infusion catheter designed for use in retrograde coronary sinus infusion procedures to infuse therapeutic agents into the heart via the […]
Sales for Abbott’s diabetes business jump 40% in Q2
Abbott (NYSE:ABT) shares were up today after the healthcare company posted second-quarter financial results that topped estimates on Wall Street. For the three months ended June 30, Abbott posted profits of $733 million, or 41¢ per share, on sales of $7.77 billion. The company saw its quarterly profits grow 159% on sales growth of 17% compared […]
Reva lands new partner in Italy for bioresorbable scaffold
Reva Medical (ASX:RVA) said today that it inked a deal with Bio Vascular Group to distribute Reva’s Fantom bioresorbable scaffold in Italy. The partnership expands Reva’s commercial activities to Italy, adding to its ongoing efforts in Germany, Switzerland, Austria and Turkey. The San Diego, Calif.-based company also touted today that the first commercial implant of its […]