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 […]
Peripheral
Inari Medical wins FDA nod for ClotTriever peripheral thrombectomy device
Inari Medical said today that the FDA granted pre-market approval in February for its ClotTriever thrombectomy device Feb. 16 and already has the 1st commercial procedure under its belt. Irvine, Calif.-based Inari said the ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature. The company also makes the FlowTriever device, which […]
Cardiovascular Systems escapes class-action kickbacks suit
Cardiovascular Systems (NSDQ:CSII) escaped a purported class-action lawsuit brought over allegations that it ran an off-label promotion and kickbacks scheme, but the reprieve could be short-lived because the case was dismissed without prejudice. St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused CSI of inducing physicians […]
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million. Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy. The company said it plans to float 1.3 million shares at $76 […]
FDA green-lights Cagent Vascular’s Serranator Alto PAD balloon catheter
Cagent Vascular said today that it won 510(k) clearance from the FDA for its Serranator Alto balloon catheter, which is designed to treat peripheral artery disease. The Wayne, Pa.-based company bills its serration technology, created by co-founder and CMO Dr. Peter Schneider, as a way to improve arterial expansion during balloon angioplasty for PAD. The device’s […]
Spectranetics wins CE Mark for smaller Stellarex DCB
Spectranetics (NSDQ:SPNC) said yesterday that it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035” device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal […]
LeMaitre Vascular pays $14m for Restore Flow Allografts
LeMaitre Vascular (NSDQ:LMAT) said last week that it agreed to put up $14 million for tissue preservation service provider Restore Flow Allografts. The deal calls for Burlington, Mass.-based LeMaitre to pay $12 million up front and another $2 million in May 2018, plus earn-puts pegged to sales performance over the next 2 years. Fox River Grove, Ill.-based Restore […]
FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB
QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]
FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]
Shockwave Medical wins FDA clearance for peripheral vessel Lithoplasty device
Shockwave Medical said today that it won 510(k) clearance from the FDA for its Lithoplasty system, which is designed to treat calcified plaque in patients with peripheral artery disease. The Fremont, Calif.-based company’s Lithoplasty device uses intermittent lithotripsy pulses to disrupt superficial and deep vascular calcium and an angioplasty balloon to expand blockages at low pressures to restore blood […]
FDA approves Medtronic’s In.Pact Admiral DCB for in-stent restenosis
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients. The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study […]