Sky Medical Technology Ltd. has cinched FDA clearance for a third indication for its geko device, a noninvasive, battery-powered wearable technology designed to increase blood flow in the deep veins of the lower legs. The Daresbury, U.K.-based company already had the agency's blessing for geko's use immediately after surgery to stimulate the calf muscles to prevent venous thromboembolism (VTE) and preoperative reduction of edema. Now the FDA has granted geko 510(k) clearance for stimulation of calf muscles to curb venous thrombosis in nonsurgical patients at risk of VTE.
PERTH, Australia – Australia's Admedus Ltd. has sold its Cardiocel and Vascucel patch business to U.S-based LeMaitre Vascular for up to AU$36.2 million (US$24.5 million), to include an AU$22.8 million up-front cash payment.
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.
Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).
The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.
TORONTO – Several U.S. and Canadian patients have recently undergone successful mitral valve surgery featuring a platform designed by Toronto-based Baylis Medical Inc. to provide more precise access to the wall separating the left and right sides of the heart. Robert Harrison, Baylis's director of research and development for cardiology, said in addition to locating the precise puncture point for mitral valve reconstruction, the Versacross transseptal solution has reduced the number of devices exchanged during the procedure to an all-in-one platform.
Angiodynamics Inc., of Latham, N.Y., is picking up Rehovot, Israel-based Eximo Medical Ltd. for $46 million up front and up to $20 million of contingent consideration related to certain technical and revenue milestones. Eximo offers laser atherectomy technology that is in a limited launch.
Radiation reduction during imaging procedures is a top priority for hospitals and health care providers. Startup Controlrad Inc. has raised a $15 million series B round to market its Trace mobile C-arm radiation reduction technology for use during fluoroscopically guided procedures. That has already been FDA cleared.
Lisle, Ill.-based Endotronix Inc. scooped up $70 million in an expanded series D funding round led by Life Science Partners. The funds will support the company's PROACTIVE-HF IDE clinical trial of the Cordella Pulmonary Artery Sensor System and further commercialization of the Cordella Heart Failure (HF) System.