Sadra Medical Announces Patient Enrollment In European Feasibility Study Of The Lotus Valve System
CAMPBELL, Calif.--(BUSINESS WIRE)--Sadra Medical, a medical device firm dedicated to developing innovative new therapies for aortic valve disease, today announced the enrollment and treatment of four new patients in the second phase of its European Feasibility Study of the Sadra Lotus™ Valve System. The system is designed to enable physicians to replace a diseased aortic valve utilizing a less invasive approach, navigating the valve through the patient's arteries using a catheter-based delivery system and thereby eliminating the need for an open chest surgical procedure. The company also announced that co-founder and board member, Fred Khosravi, has accepted the role of Chairman of the Board.
Each patient presented with severe aortic stenosis and was not a candidate for surgical therapy. All were treated by Professor Eberhard Grube and Dr. Ralf Müller at the Helios Klinikum Siegburg in Germany. Lotus Valve deployment time averaged 16 minutes. Post-implantation valve function was good, with no perivalvular leakage observed.
"The percutaneous aortic valve replacement (PAVR) procedure using the Sadra Lotus Valve is enhanced by the ease of placement and the ability to safely reposition or retrieve the valve," remarked Professor Grube, principal investigator for the Sadra Lotus Valve European feasibility study. "Based upon the one year follow-up from the first patient and my experience involved in treating this latest set of patients, I am very encouraged about the Lotus Valve's potential to improve the PAVR procedure."
"We are committed to engineering breakthrough design features needed to improve PAVR, enabling more patients to benefit from this life-saving therapy," commented President and CEO, Ken Martin. "The progress made in the clinical use of the Lotus Valve System is a result of the team's dedication and close collaboration with Professor Grube's group."
Regarding the company's board leadership announcement, in his expanded role as chairman, Mr. Khosravi will work closely with President and CEO Ken Martin to provide strategic direction and guidance. "I am very pleased to have Fred playing a larger role at Sadra," commented Mr. Martin. "Fred's experience and insight will play a critical role in supporting Sadra's rapid evolution as the leading second generation percutaneous aortic valve company."
Mr. Khosravi is Managing Director of Incept LLC and has co-founded eight companies, including EndoTex, Embolic Protection, Inc. (EPI), both acquired by Boston Scientific Corporation, Confluent Surgical, acquired by Tyco Healthcare, and is currently President & CEO of another Incept company, AccessClosure, Inc. Prior to his entrepreneurial career, he held management positions at Focal, Inc., Guidant, and Alcon Surgical.
"I have had the great pleasure of working with Fred on a number of important technologies and am extremely pleased to see him becoming more involved with Sadra, a company I am very excited about," observed Professor Eberhard Grube, principal investigator for the Sadra Lotus Valve European feasibility study. "Percutaneous aortic valve implantation case volumes are growing quickly in Europe, but current devices are unforgiving and must be placed perfectly the first time. We need a repositionable device like the Lotus valve to make this a routine procedure. I look forward to working with Fred and Ken to bring this exciting technology to fruition."
Surgical aortic valve replacement is the gold standard for treating symptomatic aortic valve disease. However, in certain patient populations and surgical situations, the risk associated with the procedure can be quite high. Since 2002, percutaneous aortic valve replacement has been under evaluation as a less-invasive alternative for symptomatic high-risk patients with stenosed (hardened) aortic valves. First generation valve implants have been used extensively in clinical trials, but lack the ability to be repositioned or retrieved, which are significant limiting factors for the therapy. The innovative Sadra Lotus™ Valve System, designed to be retrievable and repositionable, helps improve and streamline the procedure that, ultimately, may enable treatment for a broader group of patients.
Sadra Medical
Sadra Medical was founded in 2003 by Amr Salahieh, Fred Khosravi 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, Pequot Ventures, SV Life Sciences, Boston Scientific Corporation (NYSE: BSX), Oakwood Medical Investors, Finistere Ventures, and Yellowstone Capital. http://sadramedical.com
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