Medtronic CoreValve, a less-invasive heart valve that has Orange County roots, recently received the green light from the Food and Drug Administration for use in what’s known as “valve-in-valve” procedures for treating people whose surgical aortic valves have failed.
Medtronic CoreValve is a product of Ireland-based Medtronic PLC, which has some 1,300 workers in OC.
About 200,000 heart patients receive surgical valves across the globe yearly. The implanted valves degenerate over time and generally last about 15 years, making a second valve replacement surgery necessary.
By that time, though, many patients usually become too weak to undergo a second open-heart surgery to receive a new valve.
The FDA’s action “showcases Medtronic’s commitment to advancing the [transcatheter aortic valve replacement] field so that more patients can receive access to this life-saving, minimally invasive therapy,” Rhonda Robb, vice president and general manager of Medtronic’s heart valve therapies business, said in a news release.
Medtronic got CoreValve in 2009 when it spent $700 million to buy Irvine-based CoreValve Inc.
“Remarkably, this makes CoreValve the first ever transcatheter heart valve replacement device to have been approved by the FDA for use in [valve-in-valve] procedures involving both high- and extreme-risk heart patients, who otherwise have limited treatment options at their disposal,” said Chicago-based Zacks Investment Service in a report discussing the approval and other Medtronic developments, including a Japanese regulatory approval for implantation in patients with severe aortic stenosis.
Medtronic’s top rival, Irvine-based Edwards Lifesciences Corp., is cleared in Europe for transcatheter valve-in-valve procedures with its Edwards Sapien XT valve for aortic and mitral use. Edwards said that the valve-in-valve procedure for implanting a valve into a surgical aortic valve is being studied in its ongoing domestic Partner II trial.
Quality Systems’ Interim CFO
Irvine-based Quality Systems Inc. recently appointed John Stumpf as its interim chief financial officer, it said in a federal filing.
Stumpf replaces Paul Holt, who spent more than 15 years with the healthcare software maker and departed to become CFO of NantHealth, a Culver City-based healthcare company.
Stumpf has been with Quality Systems since 2012, serving as its senior vice president, corporate controller and treasurer. The certified public accountant was previously a production systems manager for Foothill Ranch-based Kaiser Aluminum Corp.
Quality Systems’ filing did not indicate a timetable for a permanent successor to Holt (see related story, page 3).
FDA OKs CardiAQ Study
Irvine-based CardiAQ Valve Technologies said this month that it received an investigational device exemption approval that will allow it to conduct an early feasibility study.
CardiAQ, which is privately held, has developed a transcatheter mitral replacement heart valve that can be delivered through a patient’s femoral artery or through an incision in the ribs. The company said in a news release that the valve has an anchoring mechanism that uses the patient’s native mitral valve anatomy, something that allows doctors to “accurately and securely implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery.”
The study will enroll up to 20 patients. Multidisciplinary teams of doctors will start enrollment once hospital approvals and agreements are in place. CardiAQ said that Beth Israel Deaconess Medical Center’s imaging core laboratory in Boston will serve as the core lab for the studies under the leadership of Dr. Jeffrey Popma, a Harvard Medical School professor and director of interventional cardiology at Beth Israel Deaconess.
Bits & Pieces
Aliso Viejo-based Vertos Medical Inc. said a clinical trial comparing its minimally invasive lumbar decompression with epidural steroid injections reached full enrollment. The trial will look at 300 patients who received treatment with mild or steroid injections. Vertos touts “mild” as an alternative to open spinal surgery for treating lumbar spinal stenosis, a main cause of back pain. … Long Beach Memorial Medical Center, a hospital owned by Fountain Valley-based MemorialCare Health System, said it is now offering hip and knee procedures using a robotic arm interactive orthopedic surgical device produced by Mako Surgical Corp., a Fort Lauderdale, Fla.-based unit of Kalamazoo, Mich.-based Stryker Corp.
