A Medical Device Daily

CardioFocus (Marlborough, Massachusetts) reported that it has received a CE mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation (AF). The EAS is the latest generation, percutaneous catheter system that has been used clinically to treat patients with AF. This novel device incorporates both a micro-endoscope and light energy fibers to give physicians the capacity to actually see within the heart, and for the first time, visually direct the application of energy through a catheter.

"The EAS represents a new era for catheter ablation of this complex arrhythmia. The CardioFocus device provides the electrophysiologist with a direct view of the cardiac anatomy that simply has not been available using other catheters. I believe that seeing the true orientation of the anatomy in full color and in real time, combined with the ability to safely and reliably deliver energy to the right target, increases the likelihood of delivering effective therapy," said Vivek Reddy, MD, Director of Electrophysiology Laboratories at The Mount Sinai Medical Center (New York).

"CE marking for our product highlights the great progress our company has made; our entire group has been dedicated to achieving this milestone. This facilitates more ambitious international research and European commercialization of our device. Cardiac electrophysiology is a focused area of medicine where a small company can make a big impact with the right product," said Stephen Sagon, CardioFocus president/CEO.

Researchers developing artificial nerve cell

Scientists at the Swedish medical university Karolinska Institutet (Solna, Sweden) and Link ping University are well on the way to creating the first artificial nerve cell that can communicate specifically with nerve cells in the body using neurotransmitters. The technology has been published in an article in Nature Materials.

The methods that are currently used to stimulate nerve signals in the nervous system are based on electrical stimulation. Examples of this are cochlear implants, which are surgically inserted into the cochlea in the inner ear, and electrodes that are used directly in the brain. One problem with this method is that all cell types in the vicinity of the electrode are activated, which gives undesired effects.

Scientists have now used an electrically conducting plastic to create a new type of "delivery electrode" that instead releases the neurotransmitters that brain cells use to communicate naturally. The advantage of this is that only neighboring cells that have receptors for the specific neurotransmitter, and that are thus sensitive to this substance, will be activated.

The scientists demonstrate in the Nature Materials article that the delivery electrode can be used to control the hearing function in the brains of guinea pigs.

"The ability to deliver exact doses of neurotransmitters opens completely new possibilities for correcting the signaling systems that are faulty in a number of neurological disease conditions", said Professor Agneta Richter-Dahlfors who has led the work, together with Professor Barbara Canlon.

The scientists said they intend to continue with the development of a small unit that can be implanted into the body. It will be possible to program the unit such that the release of neurotransmitters takes place as often or as seldom as required in order to treat the individual patient. Research projects that are already under way are targeted towards hearing, epilepsy and Parkinson's disease.

Spectrascience in French distribution partnership

SpectraScience (San Diego) reported that it has established a distribution partnership in France through Medipartner (Paris), a firm specializing in the marketing and distribution of gastrointestinal devices.

The company said it believes that building an effective distribution network in France will also enhance sales in the emerging North African and Middle Eastern markets due to their relationship with France.

"We decided to add the WavSTAT to products that we distribute because it is both innovative and it will translate into progress for cancer detection. Our focus is in the gastrointestinal market, and based on our experience and understanding of that market, I think that the WavSTAT is a great fit for us, and our customers," said Medipartner's CEO, Christian Arnould.

The company's WavSTAT optical biopsy system uses light to optically scan tissue and provides the physician with an immediate analysis. In addition, the company's Luma cervical imaging technology has received FDA approval as an optical non-invasive system that is proven to more effectively detect cervical cancer precursors than conventional methods available today.

Berlin Heart reports restructuring

Berlin Heart (Berlin) reported that Dr. Johannes Mueller, the company's general manager, CEO and CSO is leaving the general management of the company at the end of September.

Mueller belongs to the company's founders and is one of the intellectual fathers of the successful ventricular assist device Incor, the company noted. The company said Mueller will continue to contribute his wealth of experience in this area as coordinator for projects with external cooperation partners. He will further support the company in developing new markets.

Mueller was a member of the general management from the very beginning when the company was founded as a start-up enterprise with venture capital in 1996.

In October, Dr. Stefan Thamasett will join the general management of Berlin Heart to succeed Mueller. Thamasett has more than seven years of experience in clinical cardiology and possesses long-standing experience as head of marketing and sales in well-known medical device companies, the company said. He will manage the company together with Dr. Dirk Lauscher, the company's present General Manager.

Berlin Heart develops implantable and external ventricular assist devices for patients of every age and body size. The products Excor and Incor provide mechanical support of the heart for patients suffering from severe end-stage heart failure.

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