Medtronic Gets Go-Ahead from FDA for Study of Novel Treatment for High Blood Pressure

Medtronic, Inc. MDT, announced today that the U.S. Food and Drug Administration (FDA) has conditionally approved the protocol for SYMPLICITY HTN-3, the company's U.S. clinical trial of renal denervation with the Symplicity® Catheter System™ for the treatment of resistant hypertension (high blood pressure in the presence of three or more medications), an especially dangerous disease affecting hundreds of millions of people worldwide. Patient enrollment in the landmark study is expected to start soon. Medtronic is leading the development of renal denervation therapy. Having received Europe's CE (Conformité Européene) mark and a listing with Australia's Therapeutic Goods Administration, Medtronic's Symplicity Catheter System is commercially available in Europe and Australia. FDA approval of the SYMPLICITY HTN-3 protocol enables Medtronic to become the first company to conduct a randomized, controlled trial of renal denervation in the United States. The Symplicity Catheter System is not approved by the FDA for U.S. commercial distribution.