SYS-CON MEDIA Authors: Doug Masi, Mat Mathews, PR.com Newswire, David Smith, Tim Crawford

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With Blood Clotting Complications Under Review, New Study Sheds Light on Why Some Ventricular Assist Devices Are Gentler on Blood

HOUSTON, TX--(Marketwired - April 04, 2014) - A new study compared heart assist devices to determine which ones cause less damage to blood while also minimizing or eliminating the risk of blood clotting and stroke or death to patients with end-stage heart disease (Journal of Biomechanical Engineering, February 2014, Vol. 136;021014-1 to 021014-9).

Researchers at Stony Brook University, New York, used advanced simulation and testing with human blood to determine that the ReliantHeart HeartAssist5® ventricular assist device (VAD) offered a distinct advantage compared to another VAD by demonstrating significantly lower blood damage and a lower risk of blood clots. The authors believe that the HeartAssist5® advantages may also translate into a clinical advantage with a significant reduction of the mandatory medications, as required with competitive devices, to reduce the risk of blood clots. Medications used to prevent blood clots can lead to more complications so the reduction of these medications can be a benefit for patients.

The biomedical engineers and hematology researchers at Stony Brook University, New York, used their new DTE (device thrombogenicity emulation) methodology for determining device thromboresistance. This metric helps define design features of the blood pump that mitigate shear-induced platelet activation and clotting. The article, presented in the Journal of Biomechanical Engineering, highlights work supported by grants from the National Institute of Biomedical Imaging and Bioengineering from the National Institutes of Health. This new DTE methodology promises to speed the complex design process of these lifesaving blood pumps reducing or eliminating the need for animal studies and possibly ensuring better clinical results sooner. The article can be found here: http://reliantheart.com/2014/03/20/thrombus-formation-patterns-absent-in-heartassist-5/.

Ventricular Assist Devices (VAD) are the new hope for heart failure patients facing extremely slim chances to receive a heart transplant. This proven technology can be implanted beside the failing heart and boost circulation, helping prevent further deterioration of the heart. One of the most famous recipients of a VAD was Dick Cheney, former vice president of the United States of America.

With approximately 7.5 million patients in the US suffering from end-stage heart failure, the Food and Drug Administration has approved the use of VADs for both bridge-to-transplant and destination therapy (long-term use to support heart function if transplant is not an option.)

The ReliantHeart HeartAssist is the smallest and lightest full support LVAD in the world, weighing only 92 grams, and is nearly silent. Because of its miniature size, it is one of the few LVADs that can be implanted above the diaphragm, adjacent to the heart, and is the most technically advanced device among the competitors in this field. It is the only LVAD with accurate, direct flow measurement system and cellular-based remote monitoring system.

The ReliantHeart HeartAssist5® VAD System has CE Mark* approval in Europe for use in patients requiring ventricular support due to end-stage heart failure as a bridge-to-transplant for patients awaiting cardiac transplantation and for destination therapy patients who are not candidates for cardiac transplantation. ReliantHeart intends to enter the U.S. market through an IDE, which will allow the HeartAssist5® to be sold for use in a clinical trial approved by the FDA to collect safety and effectiveness data.

*The European Union applies the CE (Conformité Européenne) Marking process to ensure patient/user safety and to enforce the manufacturer's device fulfills what it is designed to perform.

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