A Medical Device Daily

Paieon (Wynnewood, Pennsylvania) reported that it has received CE mark approval for its C-THV system, which is designed to facilitate the optimal delivery of transcatheter heart valves. C-THV assists in all procedure phases, from planning, through real-time navigation and positioning, to post-deployment analysis.

During the planning phase, C-THV assists in: finding the optimal projection (perpendicular to the aortic annulus); determining the correct device size; and planning the optimal device position in relation to the aortic annulus. Throughout the device positioning procedure, C-THV tracks both the aortic annulus and the device in real time. This enables the physician to navigate the THV accurately to its precise predetermined location. Real-time device tracking and clear viewing of the desired deployment location help the physician to better position the THV and prevent malpositioning. Following device deployment, C-THV measures the expanded device diameters for post-deployment analysis. Valve under- and over-expansion can be detected, and under-expansion can be corrected accordingly.

"We believe that the C-THV system will assist physicians in performing this complex procedure and will promote the use of high-end THV technology by providing valuable support during procedure planning and device navigation," said Omer Barlev, Paieon CEO.

OSI's Spacelabs unit in accord with dabl

OSI Systems (Hawthorne, California), a vertically-integrated provider of specialized electronic products for critical applications in the Security and Healthcare industries, today announced that its Healthcare division, Spacelabs Healthcare (Issaquah, Washington), has entered into an agreement with Irish software firm, dabl (Dublin, Ireland). Under the terms of the agreement Spacelabs will promote and offer for sale the dabl 24 hour ambulatory blood pressure monitoring (ABPM) software in conjunction with its ambulatory blood pressure monitors to general practitioners and pharmacies in the UK and Italy.

OSI Systems CEO, Deepak Chopra, said, "Spacelabs has long been considered the 'gold standard' equipment provider for ABPM monitoring equipment within the acute care and hospital markets. This new partnership with dabl, initially for the UK and Italy, enables primary healthcare practitioners and local pharmacies the ability to provide fast, reliable and interpretive reports to dramatically help improve patient care and management."

Uncontrolled blood pressure is one of the highest risk factors for strokes, heart attacks, cognitive impairment and a range of other cardiovascular conditions. Medical research now shows that relying solely on a one-off blood pressure test can be highly inaccurate. Current guidelines specify that the most accurate measurement for blood pressure is over a 24-hour period, commonly called ABPM. Traditionally the use of ABPM was restricted to specialist centers that had the expertise to interpret the data.

The dabl ABPM system is designed to automatically interpret the data making this important investigation accessible to general practice and pharmacy and improving the overall standard of reporting.

Corventis Avivo system receives CE mark

Corventis (San Jose, California), a developer of wireless cardiovascular solutions designed to enable early detection, prevention and treatment of cardiovascular conditions reported that it received CE marking for its Avivo mobile patient management system.

Physicians and patients in the European Union and other countries that accept CE mark now have access to the company's noninvasive, wireless solution to evaluate physiological changes and monitor signs of cardiac irregularities in patients away from the hospital.

The Avivo system was designed to provide focused insight into the cardiac health status of patients, such as those suffering from heart failure, by combining the patient-friendly PiiX wearable sensor with advanced computational algorithms, global wireless capabilities and a comprehensive web-based infrastructure. Physiological trends including heart rate, heart rate variability, respiratory rate, fluid status, activity and posture are captured and automatically transmitted for personalized review by healthcare professionals. Physicians are also provided actionable information when an irregularity in the patient's cardiac rhythm occurs, helping to further diagnose potential health risks remotely from anywhere across the globe.

Accumetrics enters agreement with Endotech

Accumetrics (San Diego) reported that it has signed a new exclusive agreement with Endotech (Como, Italy) for distribution of its VerifyNow system in Italy. With the addition of Endotech to Accumetrics' growing number of distribution partners, Accumetrics now has local representation in 25 countries in Europe, Latin America and Asia/Pacific.

The VerifyNow system helps physicians assess patients' response to life-saving antiplatelet therapies, such as aspirin, Plavix, Effient, and GP IIb/IIIa inhibitors. As response to these drugs varies, the tests help physicians ensure their patients on antiplatelet medications are receiving the optimal benefit.

Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing diagnostic tests for rapid platelet function assessment.