Medtronic (NYSE:MDT) implanted its CoreValve transcatheter aortic valve implantation system into the first patient in a Japanese clinical trial of the device’s safety and effectiveness.
The CoreValve system is a minimally invasive treatment option for patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.
"With the number of aortic valve stenosis patients steadily rising as the Japanese population ages, we consider this an important step towards the introduction of a new therapeutic option to the health care system," lead surgeon and professor in the cardiovascular surgery department at Osaka University Hospital Dr. Yoshiki Sawa said in prepared remarks.
The device, currently limited to investigational use in the U.S., won approval from Korean regulators earlier this month and expanded CE Mark approval in the European Union in August, but is still years away from the U.S. market.
CoreValve "looks like a 2014 product for the U.S.," Medtronic executive VP and cardiac and vascular group president Michael Coyle said at an annual shareholders meeting in August.
Edwards has staked its flag on an October 2011 release, sinking about $40 million into a launch that Edwards’ chairman & CEO Michael Mussallem said will allow the company to compete in 200 to 400 medical centers in the U.S.
Edwards and Medtronic have gone back and forth over valve patent disputes, most recently resulting in a $74 million patent infringement loss for Medtronic. A federal judge denied Edwards’ move to bar U.S. manufacturing and sales of CoreValve, which Medtronic acquired in in its $700 million buyout of CoreValve Inc. in 2009.
Medtronic also announced a novel approach to minimally invasive spinal fusion allowing surgeons to access the spine in the lower back, according to a press release.
Claret Medical Inc. announced today that its Montage System has received CE Mark approval as the world’s first complete system of filtration to protect both carotid arteries simultaneously.
LDR, a privately held spinal implants company, announced that it received 510(k) clearance to market the ROI-A Oblique ALIF cage.
"I am able to report to you that our October 17, 2011 meeting with the FDA went as anticipated and we have successfully completed the second milestone of our three phase submission process," Imaging3 (OTCBB: IMGG) chairman & CEO Dean James said in prepared remarks.
ClearCount Medical Solutions announced received approval to affix the CE mark to its SmartSponge and SmartWand-DTX products. The SmartSponge product line is the first and only RFID-based surgical safety and efficiency technology bearing a CE mark, according to a press release.
Brainsway (TASE:BRIN) received an Investigational Device Exemption approval from the FDA, allowing it to begin a multicenter clinical trial to evaluate the efficacy of its Deep TMS device in the treatment of subjects with bipolar disorder.