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 […]
Vascular
Contego Medical wins CE Mark for Vanguard IEP angioplasty system
Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region. The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an […]
LimFlow wins FDA IDE to launch end-stage CLI treatment trial
LimFlow said today it won FDA investigational device exemption to launch a feasibility study of its LimFlow percutaneous deep vein arterialization system in patients with end-stage critical limb ischemia. The company said that the study will examine the use of its system in treating CLI patients facing major amputations. The system is designed to bypass blocked […]
Medtronic touts long-term data from VenaSeal studies
Medtronic (NYSE:MDT) touted 3-year outcomes from a pivotal clinical trial and 1-year data from the Waves study of its VenaSeal closure system in patients with venous reflux disease. Dr. Kathleen Gibson, from Lake Washington Vascular, presented the data at the 2017 Charing Cross Symposium. Both studies demonstrated long-term clinical benefits and improvement in quality of […]
Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 […]
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 […]
Cardiovascular Systems recalls saline pumps
Cardiovascular Systems (NSDQ:CSII) launched a voluntary recall yesterday of its 7-10014 saline infusion pump, telling customers that they can continue to use the device until they receive a replacement. The pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomay device. The company found that electromagnetic interference from the […]
Avinger to lay off a third of workforce
Avinger (NSDQ:AVGR) said yesterday that it plans to lay off a third of its workforce and examine its “strategic alternatives” as it focuses on its Pantheris peripheral artery device. The layoffs, affecting 131 workers, are slated to be complete this week, the Redwood City, Calif.-based company said, including cutting its field sales force by nearly half, from […]