A Medical Device Daily

Ivax Diagnostics (Miami), a fully integrated global in vitro diagnostics company, reported that its subsidiary, Diamedix (also Miami), has signed a distribution agreement with Nova Century Scientific (Burlington, Ontario), a Canadian distributor and manufacturer of diagnostic kits and laboratory supplies. Through this agreement, which marks Ivax Diagnostics' entry into the Canadian market, Nova will market and sell 50 of Diamedix's products, including analyzer instrumentation, under the Diamedix brand. Nova distributes products to hospitals, clinical laboratories and research institutions across Canada, and is a subsidiary of Immco Diagnostics (also Burlington).

"This agreement, which is the second exclusive distribution agreement we have signed during the first quarter of 2010, reflects our strategy of continuing to expand our suite of high quality, reliable products, into new geographical areas," said Charles Struby, PhD, president/CEO of Ivax. "This agreement also reflects the broadening of our collaboration with Immco Diagnostics, with whom we expanded our relationship in July 2009, and for whom we are currently distributing products in the U.S. and Europe."

Data shows utility of RMR in sCAD diagnosis

Newly published data shows using a Respiratory Modulation Response (RMR) is a novel, non-invasive measure to quickly and accurately detect the presence of significant coronary artery disease (sCAD). Patients in the study with sCAD had a lower RMR compared to patients without, regardless of their risk factors or clinical history of angina, previous myocardial infarction (MI), or angioplasty. These data, published in the current issue of Euro Intervention Journal, demonstrate that RMR was lower in patients with sCAD compared to those with non-significant CAD, regardless of their risk factors or clinical history of angina, previous MI, or angioplasty.

Researchers at Rabin Medical Center (Tel Aviv, Israel) used a respiratory stress test developed by Israel-based Spirocor. The test uses a Pulse Oximeter (PPG) to measure a patient's blood flow in the finger in response to his or her paced breathing for 70 seconds. PPG data captured in the study are recorded immediately and analyzed using a proprietary algorithm that determines the RMR in a percent value. The findings of this study were further validated in research recently published in Cardiovascular Revascularization Medicine.

"Identifying significant coronary artery disease through non-invasive testing is very challenging," said Ran Kornowski, MD, director of interventional cardiology at Rabin Medical Center. "This study shows that the Spirocor test is a simple and non-invasive test that independently predicts significant coronary artery disease in patients referred for a coronary artery evaluation."

The test is not yet cleared for use in the U.S. The safety and efficacy of the test compared to stress electrocardiography in detecting s-CAD is the subject of the pivotal 1,000-patient SCORE (Spirocor Coronary Outcome by Respiratory stress Examination) study that is currently ongoing.

In this study, the RMR test was performed on a total of 97 consecutive patients referred for coronary angiography to exclude sCAD. Coronary angiography was performed on all subjects and analyzed by cardiologists who were blinded to the RMR results.

The mean patient age was 62, and the majority was men (77%). There were no significant differences between patients with sCAD and those with non-sCAD with respect to risk factors. Patients with sCAD had more incidences of recent MI, while patients without sCAD had not had recent MI. No side effects were reported during the study.

The respiratory stress test system developed by Spirocor features a non-invasive PPG finger probe connected to a computer with analyzing software residing on a central server, accessed via the internet. The patient performs a controlled breathing exercise which consists of inhaling and exhaling seven times. The PPG signal is automatically captured and the data transmitted for analysis. The RMR test has been renamed as the RSR (Respiratory Stress Response). The RSR report is automatically generated and made available on a password secured Web site for the cardiologist to review and make a decision regarding the next diagnostic and therapeutic step.