FDA Names Chief Officer for Pediatrics
The FDA has named Vasum Peiris as chief medical officer for pediatrics and special populations in the agency’s device center, effective Aug. 24. Peiris will report to the associate director for science and strategic partnerships, a role currently filled by Kathryn O’Callaghan. Peiris serves as chief of pediatric and adult congenital cardiology at the Texas Tech University School of Medicine. He has not yet announced his priorities for the role, FDA spokesman Eric Pahon tells IDDM.
FDA Approves Parkinson’s Treatment
The FDA on Friday approved St. Jude Medical’s Brio Neurostimulation System, an implantable deep brain stimulator device to help reduce symptoms of Parkinson’s disease and essential tremor. The agency based its approval on two clinical trials that showed a majority of patients were able to control their symptoms without the need for medication. The system comprises a small rechargeable electrical pulse generator implanted in the upper chest with wire leads that attach electrodes to the brain. About 1 million people have Parkinson’s disease and several million more suffer from essential tremor.
Linkage Gets CE Mark for PCR HLA Test
South San Francisco, Calif.-based Linkage Biosciences secured CE mark approval for its LinkSeq human leukocyte antigen test. The product is the first commercially available HLA testing platform compatible with real-time polymerase chain reaction technology, which enables identification of all classical HLA genes in one test, the company says. LinkSeq is indicated for organ and tissue evaluation for patients awaiting transplants.
FDA OKs Actavis’ Breast Implants
Actavis’ Naterelle Inspira breast implants have won FDA approval, the Parsippany, N.J., devicemaker says. The products are contraindicated for women with active infections, with existing cancer or precancer of their breast who have not received adequate treatment and for women who are pregnant or nursing. The devicemaker also warns that complications may result from breast implant surgery.
St. Jude Resumes Portico Trial
St. Jude Medical will resume its U.S. clinical trial of the Portico transcatheter aortic valve implantation system. The trial was launched in May 2014, but was paused in September after reports surfaced of reduced leaflet motion in study subjects. An FDA review determined that the leaflet motion was coming from the control arm of patients implanted with commercially available TAVR systems, the company says. The leaflet motion has occurred in TAVR and surgical valves throughout the industry and is not linked to adverse events, St. Jude says.
Outset Gets $91M for Dialysis System
Outset Medical has secured $91 million in equity and debt funding to further commercialize its Tablo dialysis system. The automated system received FDA clearance for acute and chronic care settings in May. The agency also approved a clinical trial to evaluate the system’s efficacy. The San Jose, Calif., devicemaker plans to use the money for a limited commercial launch this year and to pursue expanded FDA approval, which would allow patients to operate the device in their homes. Fidelity Research and Management Co., Warburg Pincus, The Vertical Group, Partner Fund Management LP, Perceptive Advisors and CRG were involved in the financing.
BSX Touts Precision Spinal Cord Stimulator
In a clinical trial, Boston Scientific’s Precision Spectra demonstrated one-and-a-half times more overall pain relief and twice as much low back pain relief than an earlier spinal cord stimulation system, the devicemaker said Wednesday. The Precision Spectra features 32 contacts, and enables greater patient coverage of key pain areas.
Medtronic Launches GastriSail
Medtronic has launched its GastriSail gastric positioning system for bariatric surgery in the U.S., Europe and Middle East, the company said Tuesday. A worldwide launch is set for later this year. The product helps to promote more consistent sleeve creation and greater efficiency during sleeve gastrectomies. During the procedure, surgeons remove an estimated two-thirds of the stomach to create a smaller, sleeve-shaped pouch. The system allows surgeons to size and decompress the stomach pouch and test for leaks without having to use any additional devices, cutting down on the risk of irritating or injuring the esophagus. The FDA cleared GastriSail for marketing in February.
Gamma Knife System Gets CE Mark
Elekta’s Leksell Gamma Knife Icon has won CE Mark approval, with University Hospital La Timone in Marseilles, France, being the first to install the device, the Swedish firm said Tuesday. The system, which features online Adaptive DoseControl technology for precise dose delivery and frameless treatment capability, can target almost any part of the brain. The hospital will treat the first patients using the system next month. FDA 510(k) clearance for the device is pending.
UMass Lowell Expands Incubator Programs
The University of Massachusetts at Lowell has opened a new incubator program for medical technologies and expanded an existing one. The Innovation Hub and the Massachusetts Medical Device Development Center, or M2D2, feature work and research space and mentoring for entrepreneurs and startups trying to break into the medtech industry. Tenants include Vantix Diagnostics, which is working to offer point-of-care medical diagnostic products, and NonSpec, a startup by UMass Lowell students who have created low-cost prosthetics for developing nations.
Spotlight Finalizes Memcine Acquisition
Spotlight Innovation announced that it has finalized its acquisition of Memcine Pharmaceuticals. The deal gives Spotlight access to Memcine’s development-stage Immunoplex vaccine platform technology, which capitalizes on the body’s natural targeting system when administering vaccine components to white blood cells. West Des Moines, Iowa-based Spotlight Innovation focuses on working with or acquiring early stage healthcare companies.