Medtech giant Medtronic (NYSE:MDT) touted regulatory wins in the U.S. and across the pond this week, with FDA clearance and CE Mark approval of the company’s Pacific Plus PTA catheter, the latest in the company’s portfolio of peripheral artery disease treatment devices.
Privately held Mercator MedSystems plans to launch sales of its Bullfrog and Cricket micro-infusion systems with the new $6.5 million in funding the California company raised in a Series B round.
Mercator will initiate sales in Europe, the U.S. and Australia, and will also use the funds to support clinical studies of its peripheral artery disease product platform.
Minneapolis-based InterValve Inc. won FDA clearance for its V8 aortic valvuloplasty balloon catheter, which features a "figure-8" shape that helps lock the device in place in the aorta, the company announced.
The FDA okay-ed the device for stand-alone balloon aortic valvuloplasty as well as for pre-dilation during transcatheter aortic valve implantation procedures, according to a press release.
Profound Medical said it launched a study of its transurethral ultrasound ablation device for treating prostate cancer
The 30-patient trial will examine whether the device, which treats the entire prostate gland in 1 session using MRI-guided ultrasound energy, can improve patients quality of life.
TriReme Medical landed a regulatory win in Japan with Shonin approval of its Glider PTCA catheter.
TriReme said it plans to begin distribution of the torqueable catheter through its Japanese manufacturing partner, Century Medical.
Pleasanton, Calif.- and Singapore-based TriReme said the Glider device is designed for difficult coronary surgical cases, such as bifurcations and highly stenosed lesions.
The FDA cleared the device for use in conjunction with Teleflex’s disposable Arrow VPS Stylet.
The new Arrow device uses micro-doppler ultrasound and intravascular electrocardiography to locate a specific location of the vena cava and cavo-atrial junction. Finding this small location in the heart is important when placing a peripherally inserted central catheter.
Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular racked up a win for another of its devices designed to close artery incisions for catheters after the FDA cleared its Air-Band radial compression device for the U.S. market.
The device is designed to help seal the radial artery after a catheterization procedure, in which the catheter is threaded into the heart via a radial artery incision in the wrist.