Direct Flow Medical Launches Transcatheter Aortic Valve System in Europe

Direct Flow Medical announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.

The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. “I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery” stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”

“We’re pleased to provide physicians with this latest advance in TAVI procedural control” stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, “The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”

A press release can be found from Direct Flow Medical website by clicking here.

St. Jude Launches First Commercial DRG Stimulation Therapy Implant in USA

St. Jude announced the U.S. launch and first post-approval implants of the St. Jude Medical Axium™ Neurostimulator System for dorsal root ganglion (DRG) stimulation to treat patients with chronic pain that has been hard to control with traditional spinal cord stimulation (SCS). First commercial implants of the device occurred at the Center for Pain Relief in Charleston, W.Va. by Dr. Timothy Deer, and at the Sutter Santa Rosa Surgery and Endoscopy Center in Santa Rosa, Calif., by Dr. Jason Pope.

In the coming weeks, DRG implants will occur in half the states in the United States. St. Jude Medical has already partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. Over the course of the year, the company expects to have more than 300 physicians across the country trained to effectively deliver DRG therapy to patients in immediate need of targeted stimulation to alleviate chronic pain resulting from moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Neuropathic pain represents one of the most prevalent yet under-treated forms of chronic pain in the United States, with an estimated one in every 10 adults over the age of 30 suffering from the condition.

Initial results from the ACCURATE IDE study, the largest study to date evaluating patients suffering from neuropathic chronic intractable pain associated with CRPS I and II or peripheral causalgia (PC), showed DRG stimulation provided patients with superior pain relief over traditional tonic SCS. Approval of DRG stimulation with the St. Jude Medical Axium Neurostimulator System was based in part on the results of this study in which patients were randomized to receive either DRG stimulation delivered by the Axium neurostimulator system or traditional tonic SCS therapy delivered by a competitor’s system.

For more information, please visit St. Jude website by clicking here.

Earlier news: St. Jude Medical Announces the European Launch of the Trifecta Surgical Valve with Glide Technology

Polymer Material Medical Devices Demand Increased in China

The size of Chinese medical device market is expected to reach 340 billion RMB by 2015, moving at a speed of an average yearly compound increasing rate of 23%.

Among tens of thousands of medical devices available in the market, demand to those devices made from polymer material keeps expanding year after year. The polymer material devices designed and manufactured to be small in size, implantable and multipurpose are estimated to be having a yearly increasing rate of 6% until 2018.