Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study. The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation. The […]
Vascular
Amsel Medical wins FDA nod for Endo Occluder
Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures. The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices. The Amsel Endo Occluder is a […]
Cultivate(MD) buys into Medical Ingenuities and its PH Band hemostasis device
Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said yesterday that it has invested in radial artery occlusion device developer Medical Ingenuities. Wheaton, Ill.-based Medical Ingenuities is developing the PH Band, a novel radial artery occlusion device intended to for patent hemostasis. “We are proud to announce that we just closed an investment from Genesis Innovation […]
Hancock Jaffe clears Colombian regulatory hurdle for VenoValve trial
Hancock Jaffe Laboratories (NSDQ:HJLI) said today that Colombia’s INVIMA, the country’s FDA equivalent, completed their review of the company’s application for a first-in-human trial of its VenoValve, clearing another hurdle towards launching the study. The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency […]
Boston Scientific offers $4B for BTG
Boston Scientific (NYSE:BSX) said today that it agreed to offer roughly $4.24 billion to acquire British medical device maker BTG (LON:BTG). The £8.40-per-share offer, worth about £3.3 billion, is a 36.6% premium over BTG’s closing price yesterday and a 51.0% premium over the stock’s 90-day volume-weighted average price, the London-based company said. BTG’s largest division makes devices for oncology […]
Avenu Medical wins CMS reimbursement for Ellipsys dialysis device
Vascular access system maker Avenu Medical said last Friday it won a HCPCS C-Code from the Centers for Medicare and Medicaid Services for its Ellipsys dialysis device and the endoAVF procedure. The San Juan Capistrano, Calif.-based company’s Ellipsys vascular access system device is designed for use with end-stage renal disease patients who require hemodialysis. The system, which […]
Stealthy vascular play Efemoral Medical raises $1m
Stealthy medtech startup Efemoral Medical has raised $1 million in a new round of equity financing, according to a recently posted SEC filing. TheLos Altos, Calif.-based company is reportedly focused n the vascular health market, and is “developing devices that restore flow in blood vessels without using potentially harmful permanent implants or resorting to limb […]
Medtronic touts 3-year Heli-FX EndoAnchor registry study data
Medtronic (NYSE:MDT) today released three-year data from the Anchor registry study of its Heli-FX EndoAnchor system, touting that it indicated the system is safe, efficient and durable in treating patients with complex aortic abdominal aneurysm anatomy, specifically those with hostile aortic neck anatomies. Results from the trial were presented by co-principal investigator Dr. William Jordan of […]
HeartFlow wins Japanese reimbursement for FFRct analysis
HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis. The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1. […]
Cerus Endovascular starts European trial of intracranial aneurysm device
Cerus Endovascular said it has enrolled the first patients in a study designed to assess the safety of the company’s Contour neurovascular system, which is designed to reduce the risk of rupture when treating patients with intracranial aneurysms. Intracranial aneurysms occur at the rate of nine per 100,000 with a wide range; in some countries, the rate is […]
Medtronic wins CE Mark for Valiant Navion thoracic stent graft
Medtronic (NYSE:MDT) said today it received CE Mark in the European union for its Valiant Navion thoracic stent graft system intended for use in minimally invasive procedures to repair lesions in the descending aorta. The Fridley, Minn.-based company said that the device is cleared for use in treating thoracic aortic aneurysms, blunt traumatic aortic injuries, penetrating atherosclerotic […]