BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
Vascular
Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These […]
GE Healthcare wins FDA nod for Visipaque coronary CT angiography injection
GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography. The new indication allows doctors to image coronary arteries of patients to help […]
Medtronic wins FDA nod for Resolute Onyx drug-eluting stent
Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent. The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer […]
Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again […]
Mercator enrolls first patient in BTK vascular disease trial
Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia. The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications […]
United Therapeutics misses estimates for Q1 rev, earnings
Shares in United Therapeutics (NSDQ:UTHR) fell today after the biotech company missed expectations on Wall Street with its 1st quarter results. The Silver Spring, Md.-based company posted profits of $178.6 million, or $3.89 per share, on sales of $370.5 million for the 3 months ended March 31, for bottom-line loss of -24% on sales growth of 0.4% compared […]
Reva plans $40m convertible note offering
Reva Medical (ASX:RVA) said yesterday that it’s planning a $40 million convertible note offering with several institutional and 1 undisclosed corporate investor to fund the company’s ongoing needs, including the clinical development of its Fantom sirolimus-eluting bioresorbable coronary scaffold. Upon issuance of the convertible notes, the company is slated to receive $32.5 in net cash […]
Medtronic touts drug-coated balloon in peripheral artery disease patients
Medtronic (NYSE:MDT) touted data today for its In.Pact Admiral drug-coated balloon in 2 sub-analyses of peripheral artery disease patients in the company’s In.Pact Global Study. The data were presented at the 2017 Charing Cross Symposium in London. Researchers presented 1-year outcomes in patients with complex lesions, as well as outcomes in a subset of patients with […]
How Boston Sci is getting drug-eluting stents and balloons into legs
Boston Scientific officials think they have a leg up when it comes to bringing drug-eluting technology to bear on peripheral artery disease. That’s because the medical device giant has decades of experience with balloons and drug-eluting stents used around the heart. When it comes to treating the narrowing arteries in the legs and thighs, Boston […]