Edwards gets IDE to study GLX tissue treatment platform

Edwards gets IDE to study GLX tissue treatment platform By Amanda Pedersen Senior Staff Writer Edwards Lifesciences (Irvine, California) said it has received a conditional investigational device exemption (IDE) from the FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. The single arm study will follow standard heart valve guidance and use historical controls. Heart valve trials typically enroll between 500 and 700 patients, Edwards said. The GLX technology will initially be studied on the company’s Carpentier-Edwards Perimount Magna Ease aortic valve, and the study may be broadened to include other devices. The primary endpoints of the trial will measure valve safety and effectiveness. “We are excited about beginning the clinical study of this unique tissue treatment platform in the U.S. with our Magna Ease valve,” said Donald Bobo, Jr, Edwards’ corporate VP of heart valve therapy. Read more »	VOT eyes AMD market with its Implantable Miniature Telescope By Omar Ford Staff Writer With more than 15 million people in the U.S. suffering from some type of age-related macular degeneration (AMD), one private company has what it thinks is a product that could help improve the sight of some of these patients. VisionCare Ophthalmic Technologies (VOT; Saratoga, California) said that it has developed a telescope implant that has been demonstrated in clinical trials to improve visual acuity and associated quality of life. The Implantable Miniature Telescope received PMA approval back in 2010, and received approval for medicare reimbursement late last year. The company launched the device earlier this year. “We started our activity in the U.S. in 2002,” Allen Hill CEO of VOT told Medical Device Daily. “Our device was in human trials from about 2002 to 2008 moving through pilot studies and a pivotal study where we follow out our patients for up to five years.” Read more »
Symmetry to distribute surgical instruments in Japanese market a Medical Device Daily Staff Report Symmetry Medical (Warsaw, Indiana), a provider of medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, said its subsidiary, Symmetry Surgical, has completed an agreement with Japan Surgical Specialty (JSS) to distribute its medical device brands in Japan. The direct engagement of the Japanese market for Symmetry Surgical is in line with the global expansion of its recently expanded business, which includes leading brands from Symmetry Surgical, formerly Codman Surgical Instruments, and SSi. JSS is part of the Intermed Japan Group (IMJ) and is focused on meeting the needs of the surgical market in Japan with clinical and service support for innovative and high quality medical devices. Read more »	Maker of cranial remolding helmets snared by warning By Mark McCarty Washington Editor The Office of Inspector General recently published a report on the internal dispute resolution process used at FDA’s Center for Devices and Radiological Health, stating that one of the remaining issues in this area is a lack of training for managers at the review branches (see accompanying story below). However, an industry consultant says the bigger training issues are at the reviewer level. Mark Duval of Duval Associates (Minneapolis) told Medical Device Daily that an ongoing lack of fidelity to the standards for determination of substantial equivalence in the aggregate amount to “legislative changes to the 510(k) program,” a problem he said managers for the most part exhibit no interest in addressing. Read more »

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