Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital. The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow […]
Catheters
Medtronic wins expanded CE Mark for Evolut R TAVR system
Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery. The Fridley, Minn.-based company touted the win, saying it is the 1st TAVI system to have received expanded indication in Europe […]
Medtronic touts 1st enrollment in Reality PAD study
Medtronic (NYSE:MDT) said yesterday it enrolled the 1st patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease patients treated with directional atherectomy and drug-coated balloons. The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and […]
UPDATE: Stryker recalls select re-sterilized AngioDynamics Soft-VU angio caths
Updated to include comment from Stryker and to adjust “reprocessed” language to “re-sterilized” Stryker‘s (NYSE:SYK) Sustainability Solutions biz said it recalled a select number of re-sterilized AngioDynamics (NSDQ:ANGO) Soft Vu omni flush angiographic catheters due to reports of tip separation. AngioDynamics said it is not associated with the recall, and that the devices affected have their own […]
BioVentrix raises $1.2m
BioVentrix raised $1.2 million in a new round of financing through the sale of convertible notes, according to an SEC filing posted this week. BioVentrix produces the Revivent TC transcatheter ventricular enhancement system designed to treat the left ventricle following a myocardial infarction or heart attack. The Revivent is designed to eliminate the need for cardiopulmonary […]
Penumbra launches Ace68 Reperfusion thrombectomy catheter
Penumbra today announced the U.S. launch of the Ace68 Reperfusion thrombectomy catheter designed for extracting thrombus in acute ischemic stroke patients. The company said the Ace68 catheter was engineered on an entirely new platform from hub to tip, which features coil winding geometry along 16 transitions to create a more optimal tracking profile. “With the Ace68 Reperfusion Catheter, […]
Novel AF cath developer Apama Medical raises $9m
Novel catheter ablation tech developer Apama Medical raised $9 million in a new round of equity financing, according to an SEC filing posted today. Apama Medical is developing novel ablation catheter technology to combine “the best elements of existing ablation technology while incorporating additional unique features to address gaps in current technology,” according to it’s […]
FDA warns Oscor on process control records
The FDA last month warned contract manufacturer Oscor on its methods for documenting process controls for the catheters and neurostimulation leads it makes, after inspections in February and March turned up a trio of violations. The federal safety watchdog said it inspected Oscor’s plant in Palm Harbor, Fla., where it makes the Adelante Magnum introducer catheter and lead […]
Cardiovascular Systems seeks Japanese clearance for Diamondback
Cardiovascular Systems (NSDQ:CSII) said yesterday it is seeking Japanese approval for its Diamond back 360 coronary orbital atherectomy system micro crown designed to treat calcified coronary arteries to prep for stent placement. The company said it submitted an application to Japan’s Pharmaceuticals and Medical Device Agency, and that if approved, it would be the 1st international market […]
Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months. The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA […]
Insurer launches trial of Avinger’s Pantheris atherectomy device
Avinger (NSDQ:AVGR) said yesterday that it is collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of its Pantheris image-guided atherectomy device designed for treating peripheral artery disease. The Pantheris device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to […]