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Medtronic Marches Ahead In Renal Denervation; Announces Symplicity’s Inclusion In US Parallel Review Program

Medtronic’s Symplicity renal denervation system has won entrance into an elite group – it is one of the first devices to be selected for the joint FDA/CMS parallel review program, launched in 2011. That distinction could help the company quickly move the device into US clinical practice once it’s FDA approved.

Medtronic PLC reached two important milestones recently for its Symplicity radiofrequency renal denervation system, a new, catheter-based treatment for treatment-resistant hypertension with blockbuster market potential. (See Also see "Renal Denervation Sparks Device Market Gold Rush" - Medtech Insight, 25 May, 2012..) In early March the company announced that the Symplicity system had been accepted for inclusion in the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS) parallel review program. The news is important because it will allow CMS to begin a coverage and reimbursement determination for the therapy while it is undergoing FDA review, potentially enabling Medtronic’s product to reach the US market with reimbursement in place, rather than waiting months or years for that important milestone, which is the typical scenario for device manufacturers today. With reimbursement in place, the company could experience much stronger demand and uptake for the device once it is on the US market.

According to Nina Goodheart, VP and general manager for Medtronic’s renal denervation business, who spoke recently with Medtech Insight, the parallel review program is a brand-new process (it was officially...

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