A Medical Device Daily

Abiomed (Danvers, Massachusetts) reported that its Impella 2.5 and Impella 5.0 circulatory support products have been approved for use in Canada by Health Canada's Therapeutic Products Program.

The company also said that the first Canadian patients have received treatment with the Impella 2.5 at the Peter Munk Cardiac Center at Toronto General Hospital .

"We look forward to working with Canadian cardiologists and surgeons to improve clinical outcomes for patients," said Michael Minogue, president/CEO and chairman of Abiomed.

Vladimir Dzavik, MD, director of the cardiac cath lab and interventional cardiology at the Peter Munk Cardiac Center , said, "We are [pleased] to be the first hospital in Canada to use this exciting new catheter-based circulatory support technology for heart failure patients. We expect the Impella devices to be key treatment options for clinicians in our cath lab and surgical suites."

The Impella 2.5 is a ventricular-assist catheter that is inserted percutaneously in the cath lab 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.

Abiomed noted that the Impella 2.5 can be inserted quickly and provides cardiovascular support for a high-risk patient population while having such percutaneous coronary intervention as a stent or balloon angioplasty. The device also can be used to provide additional blood flow to patients with low cardiac output, such as post-cardiotomy, or to protect the muscle of the heart following a heart attack.

The product also is available in Europe, and Abiomed recently reported that it has completed enrollment for the pilot study of the Impella 2.5 in the U.S.

Abiomed's Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down or surgically. The company said these pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion.

The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac-assist devices. They are currently available in Europe and are in pilot studies in the U.S. under an Investigational Device Exemption.

Enrollment completed for genetic test studies

Interleukin Genetics (Waltham, Massachusetts) said it has completed patient enrollment in clinical studies in Japan and China as part of its preparation for the planned launch of genetic tests in Asian markets in 2009.

In collaboration with investigators at Tongji Medical College (Wuhan, China), 1,300 subjects who have cardiovascular disease or are healthy controls have been enrolled in the clinical study.

The other study, in collaboration with the New Medical Research System Clinic (Tokyo), completed enrollment of 400 subjects ahead of schedule. The study in Tokyo is focused on genetic variations, bone loss and osteoporosis in post-menopausal women in Japan.

Interleukin said it expects completion of data collection for both studies by the end of next month.

"Interleukin Genetics expects to provide multiple genetic tests for commercial launches in Asia in the next few years through our global partnership with Alticor , or possibly with other partners through more traditional medical channels," said Chief Scientific Officer Ken Kornman. "As in North America, we will provide tests that have been scientifically validated and that provide important information to help individuals live healthier lives for longer periods."

Kornman added: "The studies in Japan and China will help [our] scientists to better understand how genetic variations that predict increased risk for heart attacks and osteoporosis may be influenced by dietary and environmental factors in different populations."

The cardiovascular disease genetics study in China is under the direction of Dr. Tangchun Wu at Tongji Medical College , Huazhong University of Science and Technology , eyeing multiple genetic links to risk for early myocardial infarction (MI) in a Chinese population. The study will focus on multiple candidate genes and their relationship to levels of inflammatory mediators and to risk for early MI.

Interleukin is collaborating with New Medical Research System Clinic to study IL-1 and other genetic factors that may lead to accelerated bone breakdown in Japanese women during the early years after menopause, the period of greatest bone loss.

The osteoporosis study is under the direction of Masataka Karube, MD, of New Medical Research Systems Clinic, and Osamu Chaki, MD, PhD, of Yokohama City University Medical Center , who is the medical adviser.

Calypte cites poster session report

Calypte Biomedical (Lake Oswego Oregon), maker of diagnostic tests for the rapid detection of antibodies to the human immunodeficiency virus (HIV), reported the results of a field evaluation of its Aware HIV-1/2 OMT (oral fluid) rapid test in South Africa .

The results were presented in a poster at the 3rd South African AIDS Conference in Durban last month.

The field evaluation was conducted on 600 clients of unknown HIV status at two Voluntary Counseling and Testing clinics in South Africa. The expected HIV prevalence rate was 30% to 40%; overall, 44% of the clients tested positive. The poster reported that "the results obtained on OMT were comparable with results on serum, and were statistically significant."

Roger Gale, Calypte's CEO and chairman, said, "We have long known the accuracy of the Aware HIV-1/2 oral fluid rapid test. The usage studies that are now being reported are focusing on the social aspects of such a test and we are pleased that there is strong sentiment for adopting oral fluid testing."

He added: "While changing long-established blood collection practice to the OMT method is a process, we believe we are gaining momentum in making oral fluid an acceptable alternative to blood testing. The recent approval of our oral fluid test in India and the subsequent interest we are seeing from the government, military and private sectors is very encouraging in this regard."