Sorin Group S.p.A. (SRN) Receives Conditional FDA Approval to Conduct RESPOND CRT Clinical Trial Using Innovative Heart Failure Management Technology
3/20/2013 10:36:35 AM
MILAN--(BUSINESS WIRE)--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.
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