SentreHeart is recalling a select number of its FindWIRZ guidewire systems over PTFE coating separation issues, according to an FDA release posted today. The recall has been given a Class I label from the FDA, which indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. […]
Vascular
Shockwave Medical raises $45m Series C for Lithoplasty device
Shockwave Medical said today that it raised a $45 million Series C round for the Lithoplasty device it developed to treat calcified vasular lesions. Fremont, Calif.-based Shockwave said Sectoral Asset Management led the round, joined by new backer T. Rowe Price and existing investors Sofinnova Partners, Venrock, RA Capital, Deerfield, Ally Bridge Group and others. Shockwave said it […]
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 […]
OrbusNeich launches Combo Plus stent
OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]
Veith 2016 Roundup: Stent grafts take center stage
Medtronic touts Endurant stent graft data from Engage study Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease. First-time results from a review of […]
Smokers have higher lifetime risk of abdominal aortic aneurysm
(Reuters) – Smokers could be doubling their risk for a type of aneurysm that is usually fatal if it ruptures, researchers say. An abdominal aortic aneurysm (AAA) occurs when the aorta, the main vessel supplying blood to the lower body, becomes enlarged or bulges due to weakening of its walls. The problem can be treated […]
Endologix shares dive on FDA request for more Nellix data
Endologix (NSDQ:ELGX) shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms. Irvine, Calif.-based Endologix said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of […]
LimFlow wins CE Mark for PAD device
LimFlow said today it won CE Mark approval in the European Union for its percutaneous LimFlow system designed for venous arterialization of the lower limbs for peripheral artery disease patients. The company said the device is designed to promote chronic wound healing and avoid major amputation using proprietary ultrasound guided catheters and nitinol stents to […]
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 […]
Coating issue rears its head for Concert Medical’s Galeo Pro guidewire
Concert Medical yesterday issued a voluntary recall notice for certain lots of its Galeo Pro coronary guidewires over issues with the polytetrafluoroethylene coating separating from the device. The company said it initiated the recall because of the risk of the PTFE coating separating or detaching on the device, which could cause PTFE particulate to enter […]
Appeals court denies inventor in patent spat with Endologix pickup TriVascular
A federal appeals court yesterday upheld a lower court’s ruling on the claim construction in a patent infringement dispute between the inventor of a vascular stent patent and Endologix (NSDQ:ELGX) acquisition TriVascular Technologies. In February, the U.S. Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board ruling that the patent was not invalid due to obviousness. […]