Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European for its percutaneous aortic valve replacement system, CoreValve.
The device is "the only transcatheter aortic valve available in the world that can treat – without surgery – patients with larger valve openings (up to 29mm)," according to a press release.
CoreValve is the largest transcatheter valve available, but can compress into a small delivery system to be deployed in the same delivery system as smaller CoreValve sizes.
This latest win fills brings the larger valve into Medtronic’s portfolio of individually sized valves, which includes 26mm, 29mm and 31 mm valves, all based on the same self-expanding platform that won CE Mark in 2007.
The system is limited to investigational use in the U.S., the Minneapolis, Minn.-based med-tech giant reported.
Minneapolis, Minn.-based Vital Images Inc. (NSDQ:VTAL) landed FDA 510(k) clearance for its universal viewer, VitreaView, which provides uniform access to all patient images. Toshiba Medical Systems Corp. completed its $273 million acquisition of Vital Images in June.
Israeli company Syneron Medical Ltd. (MKT:ELOS) won FDA 510(k) clearance for its Tanda Luxe light emitting diode home device for treatment of wrinkles and fine lines. It expects to launch commercialization in the fourth quarter.
- Avinger touts FDA clearance for Wildcat catheter
Redwood City, Calif.-based vascular disease treatment company Avinger Inc. landed FDA clearance to market its Wildcat catheter for crossing chronic total occlusions to help treat peripheral artery disease. The Wildcat device creates a small channel in a totally blocked artery to make room for treatment via balloon angioplasty, stent or atherectomy.
- U-Systems lands Canadian approval for ultrasound-based breast cancer screening
Sunnyvale, Calif.-based U-Systems won Health Canada approval for its ultrasound breast cancer screening system, an adjunct to mammography for screening asymptomatic women. The device won CE Mark in September of last year.
- NeuroLogica announces CE mark for portable SPECT camera
Danvers, Mass.-based NeuroLogica Corp. won CE Mark for its portable inSPira HD high-resolution single photon emission computer tomography (SPECT) camera, designed primarily for brain imaging. The device won 510(k) clearance in September 2009.
- Vapotherm lands FDA clearance for Precision Flow nasal drug delivery system
Stevensville, Md.-based respiratory care company Vapotherm won FDA clearance for its flagship Precision Flow drug delivery system for administering nitric oxide via high flow to the nasal cannula.
- AccuVein touts Chinese marketing approval for vein illumination device
Long Island, N.Y.-based medical imaging company AccuVein Inc. won approval to market its AV300 vein illumination device in China, bringing the device’s footprint to 88 total countries.
- Zyga wins updated indication for SImmetry spine fusion device
Minneapolis, Minn.-based spinal tools company Zyga Technology Inc. announced that the FDA approved expanded use for its SImmetry sacroliliac joint fusion device, which is now indicated for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." The device originally won FDA clearance in January.