Regulatory Setback For Medtronic's High Blood Pressure Device - FDA Backed Japanese Firms' Similar Device For Uncontrolled Hypertension

Medtronic Plc MDT says the FDA Circulatory System Devices Panel (CSDP) voted unanimously (13-0) on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure, Spyral Renal Denervation (RDN) System.

But the Committee's vote was closely divided on the benefit/risk profile of the device (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote, recommending against the approval of Medtronic's blood pressure treatment device, saying associated do not outweigh the benefits.

Late Tuesday, the same FDA panel backed Recor Medical Inc. and its parent company, Otsuka Medical Devices Co Ltd's OTSKF OTSKY hypertension (high blood pressure) treatment.

The panel's unanimous vote of 12 to 0 was cast in favor of the device's safety, while a majority vote of 8 to 3 favored its efficacy. An additional favorable outcome emerged from the Committee's vote of 10 to 2, indicating that the benefits of the Paradise system outweighed the associated risks.

"We appreciate the robust conversation that occurred prior to the vote," Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, Medtronic, said in a statement, adding that the company will continue to collaborate with the FDA on bringing a new option.

The FDA will consider the panel recommendation as it continues to review the Medtronic Symplicity Spyral RDN System for U.S. market approval.

The Symplicity Spyral multielectrode renal denervation catheter and the Symplicity G3 RF Generator are indicated for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of antihypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.

Price Action: MDT shares are down 1.24% at $82.64 during the premarket session on the last check Thursday.