Archive for the 'Defibrillator' Category

FDA authorizes Physio-Control to market LIFEPAK 20e defibrillator

The U.S. Food and Drug Administration has granted clearance to Physio-Control, Inc. for the commercialization of LIFEPAK 20e defibrillator/monitor in the United States. The device is an enhancement of the LIFEPAK 20. The new features include a stronger (Lithium-ion) battery and an on-screen fuel gauge. The novel version, also, is designed to facilitate easy transportation. This will help the hospitals to meet the standards set by Joint Commission for Accreditation of Healthcare Organizations to ensure the availability of resuscitation services in all the areas.

Sunshine Heart C-Pulse implantable heart assist device passes 5-year durability testing

The Polymer Technology Group (PTG) indicated that its customer, Sunshine Heart Inc., has passed the five-year milestone on durability-testing of its C-Pulse implantable heart assist device. C-Pulse is designed to be a non-blood-contacting heart assist therapy for treating patients with moderate to severe heart failure, a condition in which the heart progressively loses its ability to efficiently pump blood throughout the body. C-Pulse includes two polymers from PTG.

C-Pulse

Boston Scientific gets Japanese approval for heart failure lead

Boston Scientific has received regulatory and reimbursement approvals from Japan for its Acuity Steerable heart failure lead. The company intends to launch the product in Japan immediately. After being implanted, the lead enables physicians to change the stimulation site in the heart without any invasion, the company said.

Europe initiates implants of Cognis, Teligen

Boston Scientific LogoBoston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.