SAN CLEMENTE, Calif. – (Business Wire) VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, announces the appointment of William H. Duffell, Ph.D. as Vice President, Global Clinical Research. Dr. Duffell will be responsible for leading all aspects of the Superion™ Interspinous Spacer IDE pivotal trial, as well as clinical development strategies outside the United States.
Dr. Duffell brings over 25 years’ experience as a senior Clinical, Regulatory and Market Development executive, possessing a wealth of successful accomplishments in both start-up and large companies. Dr. Duffell recently served as Sr. Vice President, Global Government Affairs and Global Regulatory and Quality Assurance with Gambro, a Swedish private equity owned firm which develops and markets medical devices, biologics and pharmaceuticals for hemodialysis, peritoneal dialysis and cell therapy.
Earlier at Cyberonics, a maker of implantable medical devices for the treatment of epilepsy and other debilitating neurological disorders, Dr. Duffell served as Vice President, Clinical & Regulatory Affairs. There he successfully led a Class III medical device for Vagus Nerve Stimulation (VNS Therapy™), through the entirety of the PMA process to ultimate approval by the FDA. Dr. Duffell possesses broad experience with the FDA and the Washington political arena, having twice served on FDA Advisory Panels, as well as in 2006 being confirmed by the White House and HHS Secretary as a sub-committee member for the Office of Public Health and Emergency Preparedness. He has twice testified before both Houses of Congress on matters affecting the healthcare industry.
“We are very pleased to have attracted a candidate of Bill’s caliber into the VertiFlex organization,” said Earl R. Fender, President & Chief Executive Officer of VertiFlex. “Given our focus on the Superion IDE Trial, his successful PMA accomplishments are of high value to the company. Bill’s considerable global experience will aid us in continuing to compile Superion clinical data which already has demonstrated success in multiple series completed by international investigators. With over 1,000 patients in 8 countries having received treatment with Superion, VertiFlex is uniquely positioned to provide the least invasive surgical treatment available for patients suffering from spinal stenosis.”
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive and motion preserving technologies for disorders of the spine. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex currently markets products globally in addition to conducting a pivotal human IDE trial for a next generation interspinous spacer. The Superion interspinous spacer is a percutaneous titanium implant that fits between the spinous processes in the lumbar spine. Superion received CE mark in 2007, and is currently undergoing an IDE pivotal trial for the minimally invasive treatment of spinal stenosis. Current investors include Aberdare Ventures, Alta Partners, Morgenthaler, and New Enterprise Associates.