A Medical Device Daily

The British Standards Institution (BSI) is performing an Onsite FastTrack Review this week of the European CE-mark application for the Companion Driver System produced by SynCardia Systems (Tucson, Arizona).

The system is intended to power the CardioWest temporary Total Artificial Heart (TAH-t) in the operating room, the ICU and for discharge.

Discharge drivers allow stable CardioWest patients to enjoy a near-normal quality of life at home while they wait for a matching donor heart. Many of these patients can shop, travel, visit family and friends and live life like people with human hearts.

The goal of the BSI program is to complete the CE-mark review process in 45 working days. SynCardia currently has the CE-mark for the CardioWest artificial heart, the "Big Blue" hospital driver and the European portable driver through BSI.

"The Onsite FastTrack Review is not for the faint of heart. It is designed for customers who have their ducks in a row and are ready to go to market in Europe," said Dr. Andre Routh, BSI senior product expert working with SynCardia. "We are working onsite with SynCardia to advance effectively toward European regulatory approval of the Companion Driver System."

"SynCardia is taking advantage of a valuable opportunity by participating in the BSI FastTrack Program," said Rodger Ford, company CEO/president. "Once we achieve regulatory approval in Europe and the U.S., we are projecting a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the following 24 months."

SynCardia said that in Europe, CardioWest artificial heart patients can wait up to two years for a matching human heart. While demand is growing, the supply of donor hearts worldwide remains flat.

In 2007, CardioWest implants accounted for 20 patient years of life on the artificial heart. In 2008, that number grew to 30, a 50% increase in patient years with only a 4% increase in the number of implants.

CE mark for MicroAccess WAND

Access Scientific (San Diego) reported receiving CE-mark approval for its MicroAccess WAND, which it calls the world's first all-in-one safety introducer. The device has already received FDA clearance.

The MicroAccess WAND enables clinicians to more quickly and safely insert a sheath or catheter into a patient's peripheral vasculature. The company said the device "combines all components of the older, Modified Seldinger Technique into a unitary device that provides faster, safer, simpler over-wire vascular access in a relatively bloodless procedure."

The MicroAccess WAND is designed to be used primarily in interventional radiology suites and cardiac catheterization labs. Subsequent iterations are expected to include the PSI (percutaneous sheath introducer) WAND, PICC WAND and Power WAND now in development. The latter two devices are designed to be used primarily by vascular nurse specialists for insertion of PICC and extended-dwell peripheral IVs.

"Accomplishing CE-mark approval is the latest step in what continues to be the steady advance toward commercializing the WAND family of safety introducers," said CEO Steve Bierman, MD, adding, "Accomplishing CE-mark approval ... [is] an important milestone in our strategy for reaching the worldwide market for these devices, which is estimated to be more than $2.5 billion annually."

The original Seldinger technique was developed in 1953 to reduce complications associated with the introduction of catheters and other medical devices into blood vessels and hollow organs, but Access Medical said that because there have been few significant improvements to the technique since it was invented, "what is now known as the Modified Seldinger Technique still carries serious risks for patients and clinicians."

The company said the WAND is designed to reduce these risks, which include accidental needlesticks, bleeding, contamination, embolism, and loss of cannulation.

Bierman said discussions are under way with international specialty distributors regarding sales of the WAND.

Nucletron, RaySearch extend collaboration

RaySearch Laboratories (Stockholm, Sweden) and Nucletron (Veenendaal, the Netherlands) have extended an existing collaboration with two new treatment planning solutions for radiation therapy. According to a new development and license agreement, RaySearch will develop software modules for Model-Based Segmentation (MBS) and treatment planning of Volumetric Modulated Arc Therapy (VMAT) for Oncentra MasterPlan, Nucletron's multimodality treatment planning system.

VMAT is a relatively new and advanced form of Intensity Modulated Radiation Therapy (IMRT), in which the target is continuously irradiated while the source of the beam rotates around the patient in single or multiple arcs. This concept enables faster treatment delivery compared to traditional IMRT, where the patient is irradiated only from a few selected angles.

The new VMAT treatment planning solution will be integrated in the Oncentra Optimizer module of MasterPlan.

The companies said MBS facilitates the segmentation process when 3-D models of the tumor and surrounding organs at risk are created prior to the treatment planning process, traditionally a very time-consuming task as the contours are outlined manually.

The new Model-Based Segmentation software module uses 3-D organ models that automatically adapt to patient image data. "Combined with highly intuitive interactive tools, this solution has the potential to significantly decrease the time spent on segmentation and also improve consistency in the process," the companies said in a statement.

The MBS solution will be integrated in the Oncentra Anatomy module of MasterPlan and will be useful for treatment planning of both external radiation therapy and brachytherapy.

"Oncentra MasterPlan represents the latest generation of treatment planning solutions," said Nucletron CEO Jos Lamers. "With the addition of VMAT support as well as a new, time-saving method for semi-automatic target definition, we believe that Oncentra MasterPlan will secure its position as the most advanced linac-independent treatment planning system on the market. Our strategic collaboration with RaySearch continues to provide radiation oncology with new and exciting functionality that will improve patient care."