The FDA last week sent a warning letter to Terumo Corp. (TYO:4543) over issues with the manufacturing and quality control of its Destination Guiding vascular sheaths. The agency warned the company over issues with the manufacturing, packing, storage and installation at the facility that produces its Destination sheaths, referencing failures around design and conformity. The […]
Vascular
Vascular Solutions, CEO Root beat criminal charges in off-label promotion case
A federal jury last week acquitted Vascular Solutions (NSDQ:VASC) and CEO Howard Root of charges that they ran an off-label promotion scheme for its now-discontinued Vari-Lase varicose vein treatment. A grand jury in the U.S. District Court for Western Texas indicted Maple Grove, Minn.-based Vascular Solutions and Root in November 2014, alleging that they created a “Short Kit” version of […]
Versago raises $1.7m for ‘reverse needle’ access port
Versago Vascular Access said today it received $1.7 million in seed funding from Primo Medical Group’s network of investors to support its “reverse needle” subcutaneous access port. West Bridgewater, Mass.-based Versago, a spinoff of Primo Medical Group, has designed and developed a subcutaneous port to access the body’s bloodstream and anatomical cavities that collect serous […]
ReCor Medical to launch U.S. trial for Paradise renal denervation device
ReCor Medical said today that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure. Palo Alto, Calif., and Amsterdam-based ReCor said the 292-patient Radiance-HTN study, a blinded, randomized and sham-controlled trial, is designed to evaluate the Paradise system in patients with essential hypertension […]
Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S.
Nipro (TYO: 8086) said this week it launched its Cronus HP high-pressure over-the-wire balloon catheter and its AquaLiner II 2nd-gen hydrophilic nitinol guidewire in the U.S. The Japanese company’s Chronus HP is a 0.035″ percutaneous transluminal angioplasty balloon catheter with indications for percutaneous transluminal angioplasty in the femoral, popliteal, iliac and renal arteries for treating obstructive […]
Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug alteplase, according to a meta-analysis of 4 previous trials of the device. The transcatheter Solitaire device uses a stent-like device to trap and retrieve a blood clot in […]
Bard touts data from Lutonix head-to-head study against MDT’s In.Pact
C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating patients with complex femoropopliteal lesions. Clinical data from the investigator-sponsored retrospective, single-center study was presented during the Leibzig International Course in Leipzig, Germany last month. The study reported […]
Cook Medical recalls select single lumen caths
Cook Medical is recalling 360 lots of its single lumen central venous catheters, pressure monitoring sets and trays due to issues with catheter tip fracture and separation. A total of 17,872 devices are subject to the recall, according to Cook, who said it began notifying customers and distributors of the issue in January and that […]
Medtronic launches Valiant TAAA stent graft study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a clinical study of its Valiant TAAA stent graft system designed as a minimally invasive treatment for thoracoabdominal aortic aneurysm. The Valiant TAAA stent graft system is designed to operate as an off-the-shelf endovascular solution for patients suffering from aortic aneurysms, which are dangerous bulging or […]
Spectranetics wins FDA nod for Bridge occlusion balloon
Spectranetics (NSDQ:SPNC) said today it won FDA 510(k) clearance for its Bridge occlusion balloon designed to temporarily occlude vessels during cardiac lead extraction procedures. The Colorado Springs, Colo.-based company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention. “The Bridge occlusion balloon […]
FDA clears Hansen’s Magellan eKit for 3rd-party caths
Hansen Medical (NSDQ:HNSN) said today it won FDA 510(k) clearance for its Magellan Robotic Catheter eKit which allows operators to control 3rd party microcatheters through the robotic system. The approval comes at least partly based on cases performed with the eKit during the Embolization Procedures in Peripheral Vasculature clinical study, Mountain View, Calif.-based Hansen Medical said. […]