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ReCor Medical Announces CE Mark Approval for Its Novel PARADISE™ Ultrasound Transcatheter Renal Denervation System


2/21/2012 6:34:45 AM

FRANKFURT, Germany, Feb. 20, 2012—ReCor Medical, an emerging medical device company, announced today that its PARADISE (Percutaneous Renal Denervation System) ultrasound platform for achieving renal denervation has received the CE mark. PARADISE is designed to treat patients with ‘resistant’ hypertension (“HTN”), a major risk factor for cardiovascular disease.

The F-I-M clinical data for PARADISE were reported at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The PARADISE data showed that systolic blood pressure was reduced by an average of 31 mm Hg in 7 patients at 60-day follow-up.

“PARADISE?is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure,” said Mano Iyer, CEO, ReCor Medical. “We are extremely pleased with our First-In-Man clinical results as we prepare to launch PARADISE in Europe.”

“The initial results with PARADISE are impressive,” added Professor Marc Sapoval, Hôpital Européen Georges-Pompidou, Paris, who is a member of ReCor Medical’s Medical Advisory Board. “This degree of blood pressure reduction has significant health benefits for patients.”

PARADISE includes a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a rapid and highly efficient renal denervation procedure. The advantage of PARADISE is its ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.

About ReCor Medical, Inc.

Founded in 2009, ReCor is a private venture-backed, early-stage company developing novel therapeutic ultrasound catheter technology. ReCor is backed by European and U.S. investors including Sofinnova Partners, one of the largest life science investors in Europe. The Company’s PARADISE™ technology for renal denervation is CE-marked. For more information about ReCor Medical, please visit the Company’s website at www.recormedical.com.



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