LeMaitre Vascular Inc. (NSDQ:LMAT) officially exited the stent graft market, taking its ball and $1.3 million home after spiking a distribution deal with Endologix Inc. (NSDQ:ELGX) and selling a pair of brands to Duke Vascular.
A Medtronic Inc. (NYSE:MDT) stent graft system for treatment of aneurysms that occur in the aorta has successfully met primary endpoints through 12 months of a clinical trial, according to the company.
In the VALOR II study of 160 patients at 24 U.S. medical centers the Valiant thoracic stent graft system showed a 97 percent success rate for treating aneurysms through 12 months, the company said.
The overall mortality rate was 12.6 percent with 3.3 percent of the patients having died of “aneurysm-related” causes.
There’s a “potentially troubling gap” in the Food & Drug Administration’s oversight of medical device clinical trials, according to the Wall Street Journal — the federal watchdog agency doesn’t inspect device-making plants during trials.
The Journal, citing the failed clinical trial of an Aptus Endosystems Inc. stent graft, said the lack of oversight means “hundreds of participants in clinical-trial studies of medical devices may be at risk of receiving faulty devices.”
Endologix Inc. (NSDQ:ELGX) won CE Mark approval for its "expanded offering" of Powerlink stent graft products and PowerFit aortic extensions in the European Union.
The company may now begin marketing and selling 31 new sizes of its Powerlink stent grafts and 18 mm to 32 mm diameter models of the company’s PowerFit aortic extensions across the pond, allowing physicians to treat a wider patient population.
Medtronic Inc. (NYSE:MDT) made the first enrollment in a U.S. clinical trial testing the use of a stent graft in patients with a potentially life-threatening cardiovascular condition.
The 50-patient trial will test the company’s Valiant Thoracic Stent Graft on patients with Type B aortic dissection, a condition in which there is bleeding into and along the wall of the aorta, the major artery leaving the heart, according to a statement from Fridley, Minnesota-based Medtronic.
Cordis Corp. enrolled the first patients in a clinical trial of a stent graft designed to treat abdominal aortic aneurysms.
The Bridgewater, N.J.-based Johnson & Johnson (NYSE:JNJ) subsidiary said the Innovation study of its InCraft stenting system will assess the device’s safety, with up to 25 patients enrolled at three sites in Germany.
LeMaitre Vascular Inc. (NSDQ:LMAT) won conditional approval from the Food & Drug Administration for a feasibility study of its TAArget thoracic stent graft it calls the Entrust trial.
The Burlington, Mass.-based vascular device maker first submitted its application for an investigational device exemption in May of last year for a study evaluating the safety of the graft, which the FDA deems a “significant risk” device. The agency granted conditional approval for the IDE Dec. 4.
Medtronic Inc. won CE Mark approval in the European Union for its Captivia delivery system for the Valiant thoracic stent graft and said it will launch the system internationally.
The Minneapolis-based devices giant said it will begin selling the device, which is classed as an investigational device in the U.S. and is still undergoing clinical trials, in countries that recognize the CE Mark.
The Burlington, Mass.-based vascular device maker said it will continue to distribute the Endologix Powerlink bifurcated stent graft through June 30, 2013. The previous deal, which was set to expire Dec. 31, 2010, has been in place since 2007.
Chairman and CEO George LeMaitre said the Irvine, Calif.-based company’s stent graft is complements his firm’s TAArget thoracic and UniFit abdominal endografts.