Minimally-invasive vascular trauma focused Pryor Medical Devices said today it won FDA 510(k) clearance for its ER-Reboa balloon catheter designed to occlude the aorta. The ER-Reboa is San Antonio, Texas-based Pryor’s flagship product, designed to occlude large vessels using a balloon for treating traumatic injuries, specifically by the critical care and emergency medicine community. “We […]
Catheters
TAVI: Direct Flow’s LeMaitre touts real-world data for next-gen heart valve
Direct Flow Medical said last week that 1-year data from a post-market study of its transcatheter aortic valve implantation system showed a 95% rate of mild or no paravalvular regurgitation. The low rate of paravalvular leaks is of primary importance to the TAVI market, Direct Flow CEO Dan LeMaitre told MassDevice.com last week, as the procedures become more common […]
TCT 2015 Roundup: Edwards presents early Forma tricuspid repair results
Edwards Lifesciences (NYSE:EW) said yesterday that data from the 1st 13 uses of its Forma transcatheter tricuspid repair system reported no deaths or major complications. The announcement was made at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco and data from the 1st 7 patients was published in the Journal of the American College of […]
TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects […]
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device. The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. […]
Corindus Vascular, Mayo Clinic sign robotic PCI research deal
Corindus Vascular Robotics (OTC:CVRS) said today it signed a deal with the Mayo Clinic to form a joint robotic-assisted percutaneous coronary intervention research and clinical program. The program will use Corindus’ CorPath robotic-assistance system designed for coronary PCI procedures. The system allows operating physicians to avoid radiation exposure and orthopedic strain from wearing lead protective vestments […]
Osprey rises on FDA 510(k) for DyeVert
Osprey Medical (ASX:OSP) said it received FDA 510(k) clearance for its DyeVert contrast modulation system, sending shares of the company to a nearly 2-month high. The DyeVert system automates contrast modulation during manual dye injections, self adjusting for catheter and contrast types without requiring user adjustments, Osprey said. “With FDA Clearance of our DyeVert System, […]
Cook expands Class I Beacon Tip recall
Cook Medical said today it expanded its recall of its Beacon Tip angiographic catheters to include all lots of select sizes of the catheters. The recall is based on 42 medical device reports of the tips splitting or separating, which leads to loss of device function and can require medical intervention or face the potential of […]
Boston Scientific, Baxter join TVA Medical’s $15m Series C round
TVA Medical said today it raised $15 million in a Series C financing round to support its everlinQ endoAVF system for creating minimally invasive hemodialysis access, with strategic investments coming from major players Baxter (NYSE:BAX) and Boston Scientific (NYSE:BSX). The catheter-based system is designed to create an AV fistula used for hemodialysis access. The system uses 2 magnetic catheters which […]
Corindus wins FDA nod for radial access stenting with CorPath
Corindus Vascular Robotics (OTC:CVRS) said today it won FDA 510(k) clearance for its robotic-assisted CorPath System for use during percutaneous coronary interventions stenting procedures performed via radial access. The approval was based on results from a 30-patient clinical trial of the device that demonstrated a 100% device and clinical success rate, the Waltham, Mass.-based company said. “Radial […]
Neuravi launches EmboTrap in Europe
Neuravi said today it launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe. The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June. […]