A Medical Device Daily
Medtronic (Minneapolis) reported the approval of its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare (MHLW), clearing the way for the launch of the product in the world's second largest market for advanced medical technology. The company said it plans to launch the Endeavor immediately following the authorization of reimbursement which is expected on May 1.
Following the launch in Japan, the Endeavor DES will be commercially available for the treatment of coronary artery disease in every major market in the world.
"The large and growing body of evidence from clinical studies and clinical practice around the world continues to demonstrate the enduring benefits of the Endeavor stent for patients with coronary artery disease," said Sean Salmon, VP of Medtronic CardioVascular and general manager of Medtronic's Coronary and Peripheral business. "We look forward to bringing these benefits to Japan very soon."
The company said that the ENDEAVOR clinical program has demonstrated that the Endeavor DES is associated with exceptionally low rates of stent thrombosis, myocardial infarction (MI) and cardiac death, as well as low rates of clinically-driven target lesion revascularization (TLR), out to as long as five years of patient follow-up. Representing various world geographies (including Japan) and patient subsets, the program has enrolled more than 10,000 subjects to date and will ultimately enroll more than 20,000 subjects in a combination of randomized controlled and single-arm trials.
ENDEAVOR Japan (n=99), a single-arm trial of Japanese subjects with a primary endpoint of TVF at nine months, reflects the consistent results of the ENDEAVOR clinical program overall and contributed to the regulatory approval of the Endeavor DES in Japan. At two years, the TVF rate in ENDEAVOR Japan was 8.7%, comparable to the same measure in other trials of the Endeavor DES, and there have been no instances of definite/probable stent thrombosis (early, late or very late), with predictably low rates of death (2.2%) and MI (2.2%).
The Endeavor DES received the CE mark in August 2005 and was approved by the FDA in February 2008.
Israeli sites added for Oxycyte trial
Oxygen Biotherapeutics (Costa Mesa, California) reported adding clinical trial sites in Israel for the planned Phase II dose escalation study of Oxycyte in traumatic brain injury (TBI).
Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier. The Israeli sites are in addition to those previously planned for Switzerland. Oxygen Therapeutics said it expects to begin the clinical trials in the second quarter.
"Israeli physicians are excited to be able to participate in this study, especially as it relates to TBI as a result of blast injury," said company chairman/CEO Chris Stern. "Unfortunately, they have had to deal with blast victims for some time, both military and civilian. They see this as something that can help them improve outcomes for the victims they treat."
He added, "They also have one of the best medical systems in the world and are especially skilled in treating TBI. So the data they collect should be absolutely first rate."
Plans call for up to six treatment sites in Israel, the same number as in Switzerland. They will use the same clinical protocol. All trials will be supervised by the Israeli affiliate of PFC Pharma Focus AG, a Swiss-based contract research organization.
Oxygen Biotherapeutics has under development Oxycyte and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs and medical and industrial applications for biosensors.
Canadian firm names two distributors
Intelligent Hospital Systems (IH Systems; Winnipeg, Manitoba), has entered into agreements with distributors in Saudi Arabia and Spain for its first product, the RIVA System (Robotic IV Automation), a self-contained unit for filling IV syringes and bags.
The company's agreement with Arabian Medical Marketing Co. (AMCO), based in Saudi Arabia, calls for AMCO to provide direct sales and service support for the RIVA System across the Middle East.
In Spain, distribution will be by Palex Medical SA.
IH Systems CEO Kevin McGarry said, "Through a focus on innovation and a commitment to high standards, AMCO's diverse range of medical products and services has set the standard for patient care expertise and appropriate use of medical technology in the Middle East. We believe RIVA will be an outstanding addition to AMCO's suite of specialty medical products and automation technology for healthcare facilities, including hospitals."
He said of his company's new Spanish distributor, "Palex's experience and knowledge relating to robotic innovation will ensure [that] our clients receive the highest standards of service and support."
Jane Arnot, vice president of sales and marketing with IH Systems, said, "One of the many attributes of the RIVA System that makes it so attractive is its flexibility to support diverse patient needs. The ability to compound individual patient doses into a range of container forms including syringes and bags makes the RIVA System an important addition to progressive healthcare facilities."