Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster subsidiary said it won pre-market approval from the FDA for its ThermoCool SmartTouch force-sensing ablation catheter, making it the 1st such device to hit the U.S. market.
Advanced Cell Technology Inc. (OTC:ACTC) successfully dosed the first patients in clinical trials of stem cell implantation for blinding eye diseases, making it only the second company in the U.S. to win FDA permission to study a therapy derived from embryonic stem cells.
ACTC’s two trials involve implantation of retinal pigment epithelial cells derived from embryonic stem cells into patients with Stargardt’s macular dystrophy and dry age-related macular degeneration.
Medical device manufacturers seeking regulatory clearances to expand catheter ablation as a treatment for atrial fibrillation got a boost from a new study published in the Journal of the American Medical Assn.
The 19-center study compared the effectiveness of ablation procedures to one of five different drug therapies in treating irregular heartbeats. It found that 70 of the 106 patients, or 66 percent, receiving ablation procedures remained symptom-free a year later, versus only 10 of 61, or 16 percent, of patients treated with arrythymia drugs. All 167 patients participating in study had previously tried at least one drug to control fibrillatons.