The brand new US renal denervation arena gained its second major competitor on Friday, with the FDA approval and immediate commercial launch of Medtronic’s Symplicity Spyral RDN system.
- Renal denervation (RDN) is intended for hypertension that can’t be controlled by conventional therapies, either due to ineffectiveness, side effects, or adherence issues
- RDN is a minimally invasive procedure that lowers blood pressure by denervating the sympathetic nerves surrounding renal arteries, reducing overactivity that can lead to hypertension
- Medtronic’s Symplicity Spyral RDN system has been in development for 14 years, and is already approved in over 70 countries globally
The Symplicity Spyral’s approval comes just 10 days after Recor Medical’s Paradise system became the first RDN system to land FDA approval, suddenly introducing two RDN systems to US clinicians and patients who were limited to pharma and lifestyle interventions before now.
The approval also represents somewhat of a comeback story, after an FDA expert panel voted against the Symplicity Spyral in August, finding that its benefits didn’t outweigh its risks (6-7 vote).
- Recor’s RDN system on the other hand, came away with a panel endorsement through a far stronger 10-to-2 vote
It’s possible that the Symplicity Spyral’s approval was helped by an updated FDA indication, positioning it as an “adjunctive treatment (aka additional treatment) in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.”
- That’s the same FDA indication as the Recor Paradise system, but represents a change from Medtronic’s PMA application which didn’t limit the Symplicity Spyral to patients also taking antihypertensives (not just for adjunctive use).
With the Symplicity Spyral’s approval now complete, eyes will be on Medtronic’s powerful commercial organization to see how they can bring RDN into clinical practice, noting the many hurdles that completely new interventions usually face when targeting a disease that’s historically been treated with medications.
Although media coverage might focus on the Spyral Symplicity’s negative panel vote, that will only matter if it doesn’t prove effective in the clinic or for Medtronic’s business.
What might not get enough coverage is how much of a monumental feat this is for the Medtronic RDN team, and what the sudden availability of two different renal denervation systems might mean for hypertension treatment in the US.
If renal denervation ends up achieving what Medtronic and Recor believe it’s capable of, we just entered a completely new era in hypertension treatment.