Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval. The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries. Get the full story at our sister site, Drug Delivery Business News.
Vascular
Surmodics to launch pivotal trial for drug-coated balloon
Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon. The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg. Get the full story at our […]
Protembis to pair with German accelerator in US expansion deal
German medical device company Protembis said today it will collaborate with the German Accelerator Life Sciences program as it looks to expand into the US and accelerate the clinical development plans for its cerebral embolic protection device. The company said its expansion into the US will be aided by mentors from the GALS program, an […]
FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations. The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use […]
Rapid Medical raises $9m in Series B for neurovascular devices
Neurovascular device maker Rapid Medical said today it closed a $9 million Series B round of financing to support its minimally invasive stroke treatment and prevention devices. Rapid Medical produces the Tigertriever revascularization device and Comaneci adjustable remodeling mesh designed for neurovascular use, the Israel-based company said. The company touted the Tigertriever as the only […]
Silk Road Medical raises $47m
Silk Road Medical said today it raised $47 million in a new funding round to support its Enroute products designed for transcarotid artery revascularization procedures. The round was led by newly invested Norwest Venture Partners and Janus Capital Management funds and joined by existing investors Warburg Pincus, The Vertical Group and CRG, the Sunnyvale, Calif.-based company […]
Intact Vascular launches Toba II BTK trial in EU
Intact Vascular today announced the European launch of the Toba II BTK clinical trial of its Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for treating critical limb ischemia. The 1st European patient in the trial was enrolled by Dr. Marianne Brodmann and Dr. Peter Reif at Austria’s Medical […]
Gore touts 1st commercial use of Tag thoracic stent graft
W.L. Gore & Associates said today its Tag conformable thoracic stent graft was used in its 1st commercial procedure after the system won CE Mark approval in the European Union last month. The procedure was performed by Dr. Giovanni Torsello and Dr. Martin Austermann of Munster, Germany’s St. Franziskus Hospital, the Flagstaff, Ariz.-based company said. “The enhanced […]
LimFlow launches pDVA end-stage CLI treatment trial
LimFlow said today it launched a US feasibility study of its LimFlow percutaneous deep vein arterialization system designed for treating end-stage clinical limb ischemia. LimFlow’s pDVA system is designed to restore perfusion to ischemic feet to relieve resting pain, promote chronic wound healing, reduce amputations and restore mobility. The system uses ultrasound-guided catheters and covered nitinol […]
FDA OKs Intact Vascular IDE app for 6-month endpoint in BTK Tack angioplasty trial
Intact Vascular said today that the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in a below-the-knee clinical trial of its Tack optimized balloon angioplasty from 12 months to 6 months. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows […]
Cerus Endo wins CE Mark for Contour neurovascular aneurysm system
Updated to correct that the company is Cerus Endovascular, with no relation to Cerus Corp. Cerus Endovascular said today it won CE Mark approval in the European Union for its Contour neurovascular system designed for treating intra-cranial aneurysms. The Fremont, Calif.-based company said the Contour system is designed with a fine mesh braid deployed at the […]