A day after announcing CE Mark approval for the next generation of its Pantheris atherectomy device, Avinger (NSDQ:AVGR) said it’s seeking a similar nod from the FDA. The bid for 510(k) clearance from the federal safety watchdog for the image-guided device covers new features including a simpler, single-balloon system designed both for apposition and blood flow occlusion and […]
Peripheral
Avinger wins CE Mark for next-gen Pantheris atherectomy device
Avinger (NSDQ:AVGR) said today that it won CE Mark approval in the European Union for the next generation of its Pantheris image-guided atherectomy device. Redwood City, Calif.-based Avinger said the new device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. It’s designed to treat blocked […]
Study: Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk
A study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding. The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm […]
Penumbra’s Q3 results top estimates
Penumbra (NYSE:PEN) yesterday reported third-quarter results that topped the consensus forecast on Wall Street and raised its sales outlook for the rest of the year, despite a nearly 100% profit slide. The Alameda, Calif.-based medical device company posted profits of $238,000, or 1¢ per share, on sales of $83.9 million for the three months ended […]
FDA clears Nitiloop’s Nova Cross micro-catheters
Israeli medical device maker Nitiloop said today that it won 510(k) clearance from the FDA for a pair of its micro-catheters. Netanya, Israel-based Nitiloop said the federal safety watchdog cleared its Nova Cross Extreme coronary micro-catheter and its Nova Cross BTK peripheral device. “We are very excited at receiving FDA clearance for the Nova Cross Extreme […]
Shockwave Medical raises $35m for Lithoplasty devices
Shockwave Medical said today that it raised another $35 million for the Lithoplasty devices it’s commercializing to treat blocked arteries. Fremont, Calif.-based Shockwave said it plans to use the new funding, which was led by new backer Fidelity Management & Research, to commercialize its existing devices for treating coronary and peripheral vessels in the U.S. and Europe […]
Philips picks up peripheral thrombectomy device maker CardioProlific
Royal Philips (NYSE:PHG) last week said it paid an unspecified amount to acquire stealthy CardioProlific and the peripheral thrombectomy catheters it’s developing. Philips said the deal for Hayward, Calif.-based CardioProlific is complementary to its $2.16 billion acquisition of Spectranetics (NSDQ:SPNC) and its own line of image-guided therapies. “The acquisition of CardioProlific will further strengthen our innovation pipeline […]
Bard wins FDA approval for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. […]
India regulator wants price caps on more coronary, peripheral devices
Indian healthcare regulators reportedly reversed course and are now asking for a quartet of medical devices to be added to a list of products under price control. India’s National Pharmaceutical Pricing Authority wants its list of price-capped products updated to include balloon and cardiac catheters, covered stents and peripheral stents, Reuters reported. If the government there approves, they […]
Teleflex’s Vascular Solutions recalls Venture catheters
Teleflex (NYSE:TFX) subsidiary Vascular Solutions is recalling its Venture line of catheters after discovering a manufacturing defect that could cause embolisms. “After an internal investigation, VSI has concluded there is a potential for excess material used to manufacture the catheter to be present within the inner lumen of the distal catheter tip. It is possible that the excess […]
Medtronic options QT Vascular’s Chocolate PTA peripheral balloon
Medtronic (NYSE:MDT) agreed to acquire an option on the Chocolate PTA non-drug-coated balloon made by QT Vascular to treat peripheral vascular disease. The purchase price is $28 million, according to Singapore’s Business Times, pegged to “achievement of certain milestones,” the company said. In February the companies inked a 5-year deal calling for Medtronic to distribute the Chocolate […]