FDA Approves Medtronic's Hypertension Device Despite Initial Doubts From Adcomm Panel

Friday, the FDA approved Medtronic plc's MDT Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure, for hypertension or high blood pressure. 

With this approval, Medtronic will immediately begin commercialization.

In August, 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.

Also Read: Investor Caution - Medtronic's Rocky Road Ahead For Hypertension Device.

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.

The Medtronic Symplicity blood pressure procedure is a minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. 

After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind. 

Although currently limited for investigational use in Japan, China, and Canada, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries worldwide.

Price Action: MDT shares are up 1.12% at $75.60 during the premarket session on the last check Monday.

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