Healthcare Industry News:  cardiopulmonary 

Devices Interventional Cardiology

 News Release - July 11, 2007

Sadra Medical Announces Successful Clinical Use of the First Retrievable, Repositionable Transcatheter Aortic Heart Valve

Designed to Enable Successful Aortic Valve Replacement Via Minimally Invasive Transcatheter Procedure

CAMPBELL, Calif.--(HSMN NewsFeed)--Sadra Medical, a privately-held, development stage Silicon Valley firm dedicated to developing innovative new therapies for aortic valve disease, announced today that it has successfully completed the first clinical use of its breakthrough transcatheter aortic valve, the Lotus(TM) Valve System. The system is designed to enable physicians to replace a diseased aortic valve without opening the chest, instead navigating the valve through the arteries using a catheter-based delivery system.

Within the last two weeks, a 93-year old female patient was successfully treated in the cath lab at Helios Klinikum Siegburg in Germany. The patient was treated by Professor Eberhard Grube who was assisted by Dr. Ralf Muller. The patient is now ambulatory and doing well. A second case, also performed in Germany by Prof. Grube, demonstrated one of the most important features of the Lotus Valve -- retrievability. In this case, the patient had a highly calcified natural valve. During the intra-procedural assessment, the doctors determined that a different sized implant was necessary for the patient's anatomy. The Lotus device was retrieved and removed easily, safely and without injury to the patient.

Prof. Grube commented on the ease of introduction, tracking and positioning of the Lotus Valve System. "It was a privilege for our team to have the remarkable opportunity of using the Lotus valve in this first worldwide case," he said. "The system's unique repositioning and the self-centering features represent a significant technological advancement, allowing us to optimally position the valve. Most importantly, we achieved excellent acute clinical results." He added, "Our center has extensive experience with transcatheter valve replacement, and these new features that facilitate positioning and allow retrieval if needed will help improve the procedure."

Surgical aortic valve replacement is the gold standard for treating symptomatic aortic valve disease. However, depending upon the patient and the situation, the risk associated with the procedure can be quite high. Since 2002, transcatheter valve replacement has been under evaluation as a less-invasive alternative for symptomatic high-risk patients with stenosed (hardened) aortic valves. These first generation valve implants have been used extensively in clinical trials. However, they lack the benefit of repositionability and retrievability, which is a limiting factor. The innovative Sadra Lotus(TM) Valve System, designed to be retrievable and repositionable, may help streamline the procedure which, ultimately, may enable treatment for a broader group of patients.

Amr Salahieh, CEO of Sadra Medical, was pleased with the success of the clinical cases. "The Lotus Valve System is the first fully repositionable technology designed to specifically address both the disease etiology of the aortic valve and the unique requirements of a transcatheter aortic valve replacement procedure," he said. "The Sadra team is extremely proud that their tireless efforts have culminated in this successful clinical experience. Our goal has always been to deliver a device that will help advance therapy for aortic valve disease and will positively impact patients' lives." He further noted, "In the second case, we saw that the system provided the physicians with more control over the procedure due to its unique ability to be resheathed and removed safely from the patient without the need for open surgery."

Treatment of aortic valve disease remains a significant and growing unmet clinical need. As many as 3 million people in the U.S. have aortic stenosis; however, only a small percentage of those are treated with the current standard of care, open-heart valve replacement surgery, using cardiopulmonary bypass. By delivering a highly-effective aortic valve replacement that reduces the risks and morbidity associated with surgery, Sadra Medical seeks to provide a therapeutic option for patients who are not being treated today.

The Sadra Lotus Valve is for investigational use only. The device is not available for sale or use in the United States.

About Sadra Medical

Sadra Medical was founded in 2003 by Amr Salahieh and a small group of leading-edge cardiovascular clinicians. The company is pioneering new therapies to minimize the invasiveness of treating aortic valve disease. Investors include ONSET Ventures, Longitude Capital, SV Life Sciences, Boston Scientific Corporation (NYSE:BSX ), Oakwood Medical Investors, Finistere Ventures, and Yellowstone Capital.


Source: Sadra Medical

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