News | October 02, 2008

Patient Enrollment Started in European Feasibility Study of the Lotus Valve System

October 3, 2008 - Sadra Medical today said the enrollment and treatment of four new patients in the second phase of its European Feasibility Study of the Sadra Lotus Aortic Heart 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.

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,” said 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.”

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, the company said 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, the company said

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