A Medical Device Daily
Abiomed (Danvers, Massachusetts) said InEK, the governmental authority for reimbursement in Germany, has granted the highest approval level available for the company's Impella Recover devices.
The new German reimbursement standard will apply to Abiomed's Impella Recover LP 2.5, Impella Recover 2.0, Impella Recover RD and Impella Recover LD, which are available in Europe under the CE mark.
The company also said that it has recently received product registration approval in France and has now commenced shipment of Impella products to customers in that country. It said that registration of Impella products in France “provides a new opportunity for sales of [our] full Impella product line in the second-largest market in Europe.”
Hospitals in Germany are required to negotiate the reimbursement of advanced technologies and treatments directly with insurance companies. Abiomed said it received a status 1 rating, the highest available, for the Impella technology to support these negotiations and future reimbursement with German government authorities.
Michael Minogue, chairman, CEO and president, said, “Abiomed has added dedicated resources for reimbursement and economic benefit analysis in markets around the world to help accelerate patient access to technology.”
The Recover LP 2.5 is a minimally invasive ventricular unloading catheter, which is inserted percutaneously via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations.
A large percentage of patients with acute myocardial infarction require a temporary mechanical support system in order to survive. The Recover LP 2.5 can be inserted quickly into acute myocardial infarction patients and provides efficient cardiovascular support for up to five days, the company said.
The Recover LP 5.0 is a ventricular unloading catheter that is placed via a femoral artery cut-down into the left ventricle. Once in place, up to 5 liters of blood per minute is pumped from the left ventricle into the ascending aorta, actively unloading the heart.
The company said the Recover LP 5.0 has been used in European centers to support patients with post-cardiotomy failure to wean, post PCI, myocarditis, cardiogenic shock or as a bridge-to-next decision.
The Recover RD is the smallest right ventricular unloading catheter and the Recover LD the smallest left ventricular unloading catheter, Abiomed said. These devices are surgically implanted and can provide longer duration support, according to the company.
CAD sets platform for European growth
CAD Sciences (White Plains, New York), which is focused on production of advanced CAD technology for MRI of the breast, prostate and other organs, reported the establishment of a core base of reference centers, research collaborators and key customer sites in Europe to serve as a platform for the company's continued expansion into that market.
The company said the creation of such relationships is “a key initial benchmark in the development of that market” and will accelerate the placement of its fTP CAD system with European radiologists to complement a growing base of installations in the U.S.
CAD Sciences received CE-mark approval last August to market its products throughout the European Union.
The company said it has placed applications personnel to support key selling relationships, which include Vedisys (Griesheim, Germany), described by CAD Sciences as “a highly-recognized distributor of high-end radiology information systems.” Vedisys Managing Director Jan Pollard said CAD Sciences' products “provide an innovative extension of Vedisys' product line and demonstrate our commitment to provide customers with high-value solutions in radiology.”
Citing the importance of the European market to the company, CAD Sciences President Andreas Muehler said, “European radiologists were early adopters of breast and prostate MRI, and consequently, many opinion leaders in those specialties reside in Europe.”
He added: “We believe a strong presence in Europe is central to the development of fTP technology as a standard tool for analysis of contrast-enhanced MRI images of cancer by radiologists around the world.”
The company said that it developed multiple beta testing sites and research collaborations with academic centers in Europe throughout 2005, including the University Clinic in Cologne, Germany; University Clinic in Essen, Germany; and the University Clinic in Vienna, Austria.
Noting that the prostate application was developed to a large extent at his institution, Dr. Thomas Helbich, associate professor of radiology at the University Clinic Vienna, said, “It is a great example of a fruitful collaboration between clinicians and industry.”
Another Italian Mobetron order
Intraop Medical (Sunnyvale, California) said it has received its third order from Italy for a Mobetron, the company's system for intraoperative radiation therapy (IORT). The order is from the Azienda Ospedaliera S. Croce e Carle, the largest public hospital in the Western Piemonte region of Italy.
The Mobetron is a portable device that can be used in virtually any operating room. The system delivers radiation therapy at the time of surgery, when residual tumor cells are most active. The device is a mobile electron-beam system that is the only portable device designed specifically for IORT treatment of various forms of cancer, Intraop said.
Giuseppe Marchetti, MD, director of the Cuneo Hospital radiotherapy department, said, “Last year alone we treated almost 1,300 new cancer patients in our department. We plan to use the Mobetron for pancreatic cancer, sarcomas, colorectal cancer and urological cancers, in addition to early-stage breast cancer.”
Ernesto Lanzotti, president of MD51, Intraop Medical's distribution partner for IORT in Italy, said the hospital “made a careful evaluation of its options, and concluded that the Mobetron was the best choice for its IORT program.”