St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.
A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.
The St. Jude devices tout advanced battery technology and circuitry that allow for a smaller device with more energy capacity. These high-powered devices are the smallest in the industry, according to St. Jude officials.
The devices’ narrow shape allows physicians to implant them using shorter incisions, and the St. Paul, Minn.-based company’s proprietary lead connecter system required less wiring inside the patient’s chest.
"The size and shape of the Unify and Fortify ST devices are significantly smaller than that of the current devices, which is truly helpful as patients in Japan tend to be smaller than those in Western countries," said Dr. Hideo Okamura from the National Cerebral and Cardiovascular Center in Osaka, Japan.
Konica Minolta Opto Inc. of Tokyo announced FDA 510(k) clearance for its Regius Sigma tabletop computed radiography reader. The device is about the size of a small consumer printer and weighs less than 70 pounds.
"With the 510(k) clearance of the REGIUS Sigma, Konica Minolta can now offer a more affordable imaging solution to low-volume sites, further extending the footprint of digital radiography to virtually any practice or clinic," says Steven Eisner, senior marketing manager for Konica Minolta.
Alameda, Calif.-based Penumbra Inc. won Japanese regulatory approval for the Penumbra System, a package of tools for removing occlusions from large vessels in the brain. This is good news for Penumbra, which recalled its Penumbra Coil in April. The company plans immediate commercialization in Japan, according to the release.
Spinal implants and surgical instrument developer X-spine Systems Inc. received CE Mark in the European Union for its Axle spinal fusion system, and the device will be distributed in Europe through the Miamisburg, Ohio-based company’s Netherlands facility. The device won FDA clearance in November 2010.
INVO Bioscience Inc. (OTC:IVOB), a medical device company focused on treatment options for patients diagnosed with infertility, completed the 40 patient Brazilian clinical trial it began in January, and the Beverly, Mass.-based company plans to submit a bid for Brazilian regulatory approval.