Bioventrix said today it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system device designed for reshaping and restoring the left ventricle. Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart. Instead, the transcatheter procedure enables placement of small […]
Catheters
Centerline Biomedical wraps up pre-clinical study, looks to Series A
Interventional vascular device-focused Centerline Biomedical said today it completed its 1st pre-clinical study evaluating its IOPS endovascular navigation technology and is looking towards a Series-A round of financing to support the device. The system, based on research from the Cleveland Clinic’s Heart & Vascular Institute, is designed to aid surgeons navigating endovascular aneurism repair procedures, with […]
Abbott warns on Topera catheter spline fracture risk
The electrophysiology business Abbott (NYSE:ABT) built around its $250 million acquisition of Topera Medical this month warned physicians about the risk that the splines on some of its Firmap catheters could fracture. Abbott EP said it received 16 reports of catheter spline fracture from October 2013 to April 18, for an incidence rate of less than 0.4%. There […]
iVascular wins CE Mark for Luminor 18 DCB
Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty. The Luminor 18 is 0.018 guidewire compatible and has an extra low profile, and joins the company’s Luminor 14 and Luminor 35 portfolio of drug-eluting balloons […]
Philips and Profound Medical extend ablation tech deal
Royal Philips (NYSE:PHG) said it extended its deal with Profound Medical to include a sales and marketing agreement to promote Profounds’ Tulsa-Pro ultrasound ablation system. Profounds Tulsa system allows for a minimally invasive, whole-gland ablation of the prostate, which will be guided by Philips MRI machines, the companies said. “Our agreement with Philips will enable us to […]
Renal Dynamics launches post-market trial for Redy 3rd-gen renal denervation device
Renal Dynamics said it launched a post-market study of its Redy renal denervation device for treating hypertension, after winning CE Mark approval for the device last November. Zug, Switzerland-based Renal Dynamics, which is owned by the Hobart Group, said the 1st patient in the trial was successfully treated at Novosibirsk, Russia’s Meshalkin State Research Institute of Circulation Pathology. […]
Mitralign drums up $40m Series E for heart valve repair devices
Mitralign said today that it raised a Series E round worth nearly $40 million for a pair of heart valve repair devices, its namesake Mitralign annuloplasty system and the Trialign device for tricuspid repair. The Tewksbury, Mass.-based company said it plans to use some of the proceeds to pursue regulatory nods for the Trialign device in the […]
WinMed looks to license or sell VariSoft guidewire
WinMed is looking for a buyer for the VariSoft guidewire developed by founder & CEO Ed Winters, inking a deal with medical device incubator Hatch Medical to broker the sale or licensing of the device. Read the full story at our sister site, Medical Design & Outsourcing.
Acutus Medical wins CE Mark for AcQMap image & mapping system
Acutus Medical said today it won CE Mark approval in the European Union for its AcQMap high resolution imaging and mapping system designed for use with its AcQMap catheter. The company’s AcQMap imaging and mapping system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D […]
CardioFocus readies HeartLight’s U.S. coming-out party at HRS 2016
Pre-market approval from the FDA in hand, CardioFocus is readying for a coming-out ball of sorts for its HeartLight cardiac visualization and ablation device at this week’s annual meeting of the Heart Rhythm Society in San Francisco. Chairman Paul LaViolette told MassDevice.com that Marlborough, Mass.-based CardioFocus is planning a selective U.S. launch for HeartLight starting […]
UPDATE: Cook Medical recalls all 4m Beacon Tip catheters
UPDATED May 5, 2016, with comment from Cook Group president Pete Yonkman. The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology, but the company expects to have replacement catheters on the market within the next several weeks. The move […]