A Medical Device Daily
ThermoGenesis (Rancho Cordova, California) said that its distributor of the CryoSeal Fibrin Sealant System in Japan, Asahi Kasei Medical, has completed its premarket approval (PMA) submission to the Ministry of Health, Labor and Welfare.
The PMA submission followed completion of a clinical trial involving use of the CryoSeal FS system on cardiovascular, orthopedic, neurosurgery and esophageal surgery patients.
The CryoSeal FS System is used to prepare hemostatic and adhesive surgical sealants from patients' own blood in about an hour. The fibrin sealant market in Japan is currently estimated at about $130 million a year, according to ThermoGenesis.
Kevin Simpson, president and chief operating officer of ThermoGenesis, said the PMA filing "is a key milestone in the development of the CryoSeal System as a new, safe, alternative source of surgical sealant for Japan, the world's largest market for conventional fibrin sealants."
Noting that conventional fibrin sealants "are prepared from pools of thousands of units of purchased plasma and bovine lung tissue," Simpson said that recent reports in Japanese medical journals "have identified these pooled products as a source of parvovirus B19 when transmitted to patients and is a cause of hemolytic anemia."
ThermoGenesis also said that it has reached agreement with Asahi for distribution of the TPD, a small, hand-held disposable that produces 8 cc of activated thrombin from 10 cc of patient blood plasma in about 30 minutes. Thrombin is a blood-clotting enzyme that surgeons use for topical hemostasis, the treatment of pseudoaneurysms and to form "platelet gels" for the treatment of damaged tissue.
Chairman and CEO Philip Coelho said that this disposable device allows surgeons to treat patients with thrombin manufactured from their own blood, instead of bovine thrombin that has been reported in peer-reviewed journal articles to cause immune reactions and severe bleeding episodes.
He said that 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 worth of such products annually.
The CryoSeal FS System has received CE mark approval. The system is not available for sale in the U.S., where it currently is being tested to control bleeding in a Phase III liver resection trial at eight clinical sites.
The TPD is not available for sale, but ThermoGenesis said it expects to soon file and receive CE mark approval from its European Notified Body. In the U.S., a PMA is being prepared to gain clearance for the TPD as a stand-alone product for topical hemostasis.
ThermoGenesis also makes the BioArchive System, an enabling technology for cryogenic archiving of stem cells for transplant, and has been a leading supplier of ultra-rapid blood plasma freezers and thawers to hospitals and blood banks since 1992.
1st installation in China for BSD Medical
BSD Medical (Salt Lake City) said that Dr. Michael Nobel, chairman of the Nobel Family Foundation and a director of BSD Medical, inaugurated the installation of the first BSD-2000 regional hyperthermia device approved by Chinese regulatory authorities in ceremonies at the Dalian No. 3 Municipal Cancer Hospital (Dalian, China).
Nobel saluted the hospital for obtaining what he termed "the latest in state-of-the-art hyperthermia equipment." He said, "Thousands of patients will come to this hospital and receive relief from their symptoms and an improvement in their quality of life because of what we are doing here today."
BSD Medical said Dalian is an economically progressive city of more than 6 million people located in the northeast of China. The Dalian No. 3 Municipal Cancer Hospital is the largest cancer hospital in the area, with more than 500 beds for cancer inpatients as well as a number of outpatient clinics.
As the first hospital in China to acquire and use the newly approved BSD-2000, the No. 3 hospital will become a training site for other installations. The system is used to superheat and kill cancer cells, as well as to boost the effectiveness of radiation and chemotherapy.
MSI sets distribution in Panama, Costa Rica
Medical Services International (MSI; Edmonston, Alberta), said it has signed agreements with medical equipment and device distributors doing business in Panama and Costa Rica for distribution of its VScan rapid HIV 1 & 2 test kits in those countries.
It said both distribution companies are well established, and have "very strong working relationships with the appropriate government bodies and/or regulatory agencies that oversee the healthcare and medical products industries in each respective country."
MSI said that in consideration of several factors, including the existence of prostitution in both countries, and Panama's mandatory HIV testing laws for women intending to work in prostitution, "it is reasonable to expect that these two countries will require up to 300,000 HIV 1 & 2 test kits in the first full year of distribution."
Panama also requires that foreign travelers who change their visa status once in the country take an HIV test administered by the Panamanian government.
Medical Services International expressed confidence that its VScan HIV 1 & 2 test kits "will quickly become very popular in these countries due to their ease of use, accuracy and the fact that the kits do not require refrigeration – especially important in the many remote areas of Panama and Costa Rica."