A study of peripheral vascular interventions in patients with peripheral artery disease (PAD) has demonstrated “high freedom” from major amputation at three years, according to study sponsor Cardiovascular Systems. The Liberty 360° study enrolled more than 1,200 patients at 51 sites across the U.S. It followed patients across the spectrum of symptomatic PAD, and included […]
FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. Get the full story on our sister […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
Hancock Jaffe touts early results of VenoValve study
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that reflux has been reduced to normal levels in four of the first patients to receive its VenoValve device, 90 days after implantation. The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg […]
Medtronic’s VenaSeal now available in India
Medtronic (NYSE:MDT) said today that it has launched the VenaSeal closure system in India for patients with chronic venous disease. VenaSeal is used in a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased veins. Using ultrasound, the physician guides a catheter through a small access site in the leg and […]
InterVene raises $15m Series B for BlueLeaf venous valve repair device
InterVene said today that it raised a $15 million Series B round for the venous valve repair device it’s developing. South San Francisco-based InterVene touts BlueLeaf as the first catheter-based treatment for deep vein reflux that doesn’t use an implant. It’s designed to form new venous valves using vein wall tissue, the company said. The […]
FDA OKs trial for Micro Medical’s below-the-knee stent
Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease. The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Ra Medical launches large registry trial for peripheral laser device
Ra Medical (NYSE:RMED) said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue. The 2,500-patient Results […]
Zoll acquires TherOx
Zoll Medical said today that it acquired TherOx and its acute myocardial infarction treatment. TherOx’s SuperSaturated Oxygen Therapy system delivers a 60-minute infusion of the patient’s super-oxygenated blood to a targeted ischemic area of the heart via a small catheter. The treatment is designed to improve microvascular flow and reduce infarct size following primary coronary […]
Mercator MedSystems raises $14m
Mercator MedSystems said last week that it raised $14.3 million from 25 investors as part of a $15 million equity round. The California-based company is developing catheter-guided micro-infusion systems for non-systemic delivery of therapeutic agents across blood vessels as a treatment for peripheral artery disease. Get the full story at our sister site, Drug Delivery Business […]
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