A Medical Device Daily
ThermoGenesis (Rancho Cordova, California) is beginning the beta launch of its TPD product this month after receiving the CE mark for it in May. The company said it would launch the small hand-held disposable with selected hospital-based blood transfusion specialists in Belgium, Holland, Italy and the UK as a first step in addressing an annual world market of $180 million.
Full European launch will occur by the end of the summer, according to ThermoGenesis.
The autologous TPD produces 8.5 cc of activated thrombin from 11 cc of a patient’s own blood plasma in about 25 minutes. Thrombin is a blood-clotting enzyme used by surgeons for topical hemostasis, the treatment of pseudoaneurysms and to form platelet gels for the treatment of damaged tissue.
ThermoGenesis said these preparations are used in a variety of medical and surgical procedures to control or reduce bleeding.
Kevin Simpson, president and chief operating officer, said, “This novel disposable device addresses a strong demand that allows European surgeons to treat patients with thrombin manufactured from their own blood instead of bovine thrombin. Bovine thrombin, rarely used in Europe, has been reported in 28 peer-reviewed journal articles to cause the immune reactions and severe bleeding episodes. Although these health risks and additional concerns about ‘mad cow’ disease have nearly ended the clinical use of bovine thrombin in Europe and Japan, the U.S. and the rest of the world utilize more than $180 million [of it] annually.”
The TPD is not available for sale in the U.S., but the company said a premarket approval application would be prepared to gain FDA clearance for the TPD as a stand-alone product.
TheremoGenesis also said that M.D. Management has been awarded the right to distribute the company’s CryoSeal Fibrin Sealant System and disposables in the Netherlands. M.D. Management will focus on the $8 million-a-year fibrin sealant market opportunity provided by orthopedic surgeons who perform 23,000 hip replacements and 17,000 total knee replacement surgeries each year in the Netherlands.
M.D. Management is a privately held firm that distributes medical technology in Europe, the Middle East, Africa and Asia.
Rudy Huylebroeck, director of global sales & marketing for hospital/wound care at ThermoGenesis, said, “hip and total knee orthopedic surgeries result in substantial bleeding, which makes them ideal for the CryoSeal FS System that can make up to 16 ml of fibrin sealant economically from the patient’s own blood.”
ThermoGenesis has received the CE mark for the CryoSeal FS System from its European Notified Body and is testing the product in European clinical trials. Additional trials are under way in Canada and Brazil, while in Japan, a pivotal clinical trial was completed late last year and a PMA filed in March.
The CryoSeal FS System is being tested in a Phase III clinical trial at 10 clinical sites in the U.S., with a PMA expected to be submitted this year and FDA approval anticipated in 2006.
More CorAide implants completed
Arrow International (Reading, Pennsylvania) said Tuesday that three additional patients have been implanted with the CorAide continuous flow left ventricular assist system (LVAS) as part of its European clinical trial of the device.
The CorAide LVAS features a Portable Electronic Module (PEM) that responds automatically to the changing physiologic needs or demands of the patient, increasing or decreasing the pump’s speed with corresponding changes in blood flow in response to a patient’s level of activity.
Five patients have received CorAide implants since the clinical trial of the device was resumed in February, including one that was implanted at a new clinical trial center, Policlinico di San Matteo (Pavia, Italy).
Physicians at the Diabetes and Heart Center (Bad Oeynhausen, Germany) have implanted four of the devices, reporting that the CorAide is performing well and allowing patients to recover rapidly from the operative procedure and begin ambulation.
The first two CorAide patients have been discharged to their homes and have reached the endpoint of the study by exceeding 90 days on the device.
An additional trial center in Germany, Deutsches Herzzentrum Berlin, will begin screening patients following its completion of the CorAide training program later this month.
Ukraine approval for VScan test kits
Medical Services International (MSI; Edmonton, Alberta) said it has received regulatory approval to sell its VScan HIV test kits in the Ukraine. The company said market studies show that it should expect to sell in excess of 750,000 HIV test kits in that country in the first year.
In addition to the Ukraine approval, MSI said it anticipates receiving additional approvals in several surrounding countries.
The company said that most of the rapid test kits for detection of HIV currently used in this region are based on the identification of the IgG antibody, “which does not show up until 90 to 120 days after infection. By then the immune system has been seriously compromised.”
The VScan test kit detects HIV exposure upon the formation of any of the antibodies (IgM, IgA, IgD or IgG). The first three antibodies all form before IgG, according to the company. The first antibody that forms after the infection of HIV is IgM, which Medical Services International said is detectable at the earliest stages (two to 11 days) of viral infection. It said that the VScan rapid test kit detects the IgM antibody, “making it much more sensitive and specific to the detection of the HIV infection than any other HIV test kit on the market.”