A Medical Device Daily

Onset edical (Irvine, California) reported receiving the CE mark for its SoloPath trans-septal access catheter, enabling marketing in the European Union and select other countries worldwide.

SoloPath features Onset's Controlled Deployment Technology (CDT), to allow percutaneous access to the chambers of the left heart and surrounding vasculature.

The private company says it has developed several product platforms based on CDT, which represents what Onset terms "a new and different approach to procedures requiring minimally invasive access to remote sites within the body."

The company said CDT "allows introduction of a dimensionally small catheter to a specific site, which once positioned, can be radially expanded to deploy a semi-rigid sheath to maintain access to the treatment site."

The catheter enters the body at a diameter roughly 50% of the size of conventional access devices. "Once placed in the body, the device is expanded in a slow and gentle manner, using radial force to create an internal diameter larger than conventional devices," the company said. It added that studies have shown that the CDT "can allow the physician to achieve access quicker, easier and with less trauma to the surrounding tissue than with conventional access procedures."

SoloPath, the first cardiovascular application of Controlled Deployment Technology, allows interventional cardiologists and electrophysiologists a percutaneous approach to access the left atrium and pulmonary veins through the atrial septum for the diagnosis and treatment of conditions such as atrial fibrillation (AF).

Atrial arrhythmias, such as AF and flutter, affect more than 2.2 million people in the U.S. alone. Onset said many analysts project this to be the next major market in the treatment of cardiovascular disease.

"The rapidly growing number of minimally invasive procedures performed by cardiac and vascular surgeons, as well as interventional cardiologists, electrophysiologists and radiologists, has dramatically increased the need for such percutaneous and minimally invasive access," the company said. "While many catheter procedures are currently performed via multiple percutaneous access sites, an ever-growing number of these procedures will benefit from the SoloPath large-lumen catheters, which only require a single access site."

Onset said the SoloPath design "allows the insertion of a small catheter that when positioned in the atrium of the heart can be gently expanded to provide a large working lumen to perform therapeutic procedures. The resulting lumen is large enough to provide access of multiple diagnostic and therapeutic catheters and instruments."

The company says that the SoloPath will offer the advantage of reduced complications resulting from less-invasive access, time and cost savings compared to conventional electrophysiology procedures, and reduced physician education and training required to perform complex coronary procedures, expanding the market for such procedures.

Onset conducted a product evaluation at several centers in 2007. The results of this study, presented to cardiologists attending the Venice 2007 Arrhythmias, a scientific conference held last October, demonstrated that a single trans-septal access using the SoloPath balloon-expandable trans-septal catheter can be performed safely and provides a stable access lumen for multiple therapeutic procedures.

The company says that plans are under way for commercialization of the device in the second half of 2008.

German firms get development grant

BioSolveIT (St. Augustin, Germany) and Proteros biostructures (Munich, Germany) reported that they have been awarded a three-year development grant from the German Federal Ministry of Education and Research (BMBF), through its BioChance program.

With the FragScreen project, the German ministry is supporting the development of fragment-based screening technologies. The objective is to develop and validate an integrated experimental and computational approach to determine binding of low-molecular-weight compounds and molecular probes.

The companies will work in partnership with the research group of Gerhard Klebe, PhD, at the University of Marburg. The consortium is completed by two unnamed global pharmaceutical companies that will contribute to the project from the perspective of the industry's requirements.

BioSolveIT and Proteros biostructures said the award "highlights the German government's recognition of the need to build joint development teams between leading academic institutions and industrial partners small and large to bridge the gap between the research lab and the marketplace, stimulating prosperity through innovation."

CardioWest training expands

Georg Wieselthaler, MD, clinical director of mechanical circulatory support, and his team from Vienna General Hospital at the University of Vienna, completed the first phase of certification training for SynCardia's (Tucson, Arizona) CardioWest temporary Total Artificial Heart (TAH-t) in Tucson earlier this week.

A leader in the use of mechanical circulatory support devices, Wieselthaler was the first surgeon to implant both the MicroMed DeBakey Left Ventricular Assist Device and the HeartWare HVAD. He also has implanted other ventricular-assist devices, including the Terumo DuraHeart LVAS.

Wieselthaler is secretary general of the International Society of Rotary Blood Pumps.

Vienna General Hospital is the 16th hospital in Europe and the 33rd hospital in the world to complete the first phase of CardioWest certification training. The third phase of that certification training is the proctored first implant of the artificial heart at that center.

Vienna General is the largest hospital in Austria, with 2,189 hospital beds. It treats nearly 95,000 in-hospital patients each year.

There currently are 24 CardioWest certified centers worldwide, with nine additional hospitals undergoing the certification process. Certified centers are located in the U.S., Germany, France, Canada and Austria, and hospitals in Sweden and Switzerland also have begun certification training.

The CardioWest TAH-t is the only FDA-, Health Canada- and CE mark-approved temporary total artificial heart in the world. Originally designed as a permanent replacement heart, it is approved as a bridge to transplant for patients dying from end-stage biventricular failure.

In the 10-year pivotal clinical study of the CardioWest heart, 79% of patients receiving the TAH-t survived to transplant.