Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial. The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the […]
Vascular
Reva implants first Fantom bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) said yesterday that the first Fantom bioresorbable scaffold was implanted in Italy. The sirolimus-eluting device is made using a tyrosine-derived polymer that is visible under x-ray. Data from Reva’s Fantom II clinical trial found that the device resulted in a 4.2% rate of major adverse cardiac events after 12 months and 5.6% after […]
Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in U.S.
Cordis and Medinol announced today that the first commercial uses of the Elunir drug-eluting stent in the U.S. were performed at New York-Presbyterian Hospital/Columbia University Medical Center and the Piedmont Heart Institute in Atlanta. The Elunir stent, developed by Medinol and distributed by Cordis, features a metallic spring tip and the narrowest strut width of […]
Svelte Medical launches pivotal trial for drug-eluting stent-on-a-wire
The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms. The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s […]
Wacker wins FDA nod to manufacture active ingredient in Chiesi’s thrombolysis drug
Wacker Biotech said today that it won FDA approval to start producing reteplase, the active ingredient in Chiesi‘s thrombolysis drug, Retavase. The medication, which is designed to treat acute myocardial infarction in adults, will be marketed in the U.S. by Chiesi and made in Wacker’s Germany-based plant. Wacker reported that it landed approval to commercially […]
Infusion catheter developer Ablative Solutions raises $4m
Delaware-based Ablative Solutions has raised $4 million as part of a $10 million round, according to regulatory filings. The company is developing the Peregrine System, an infusion catheter that delivers diagnostic and therapeutic agents to the perivascular space surrounding blood vessels. The 510(k)-cleared device includes three microneedles that remain within radiopaque guide tubes prior to […]
FDA approves IV drug to treat dangerously low blood pressure
The FDA today approved an intravenous injection drug to treat low blood pressure in adult patients with septic shock. The drug, Giapreza, is made by La Jolla Pharmaceutical (NSDQ:LJPC) and was given priority review by the FDA. “Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death,” Dr. […]
Cordis, Medinol win FDA nod for Elunir drug-eluting stent
Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in […]
Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat
A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR). The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a document filed by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of […]