Finally: Medtronic’s Symplicity Spyral Renal Denervation System Secures FDA Approval After Decade-Long Effort

Medtronic has achieved FDA approval for its Symplicity Spyral renal denervation (RDN) system, marking a pivotal moment after a decade of pursuit. The device targets uncontrolled high blood pressure and is set for near-term commercialization. Jason Fontana, VP of marketing and strategy for Medtronic, expressed the company's readiness to initiate commercialization, emphasizing the importance of ensuring safe procedures and building the market effectively.

The simple procedure is a minimally invasive approach to delivering radiofrequency energy to nerves near the kidneys that can contribute to high blood pressure. The procedure involves inserting a single thin tube (catheter) into the artery leading to the kidney, delivering energy to calm overactive nerves connected to the kidney. Following the procedure, the tube is removed, leaving no implant behind.

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This FDA approval comes a few months after an advisory committee initially voted against the technology. Despite the earlier setback, Medtronic persevered, and the recent approval underscores the significance of the Symplicity Spyral RDN system in addressing uncontrolled high blood pressure.

Medtronic obtained the technology through the acquisition of Ardian in 2011 for $800 million. The path to approval faced challenges, including a failed hypertension study in 2014, leading to some companies exiting the space. ReCor Medical, however, persisted and gained FDA approval shortly before Medtronic's Symplicity received the green light.

Jason Fontana acknowledged the benefit of having more players in the space, emphasizing the positive aspect of competition. He highlighted the need for differentiation and building out the therapy, emphasizing the potential benefits of having multiple players contributing to advancements in the field.

With FDA approval secured, Medtronic's focus shifts to reimbursement considerations. Fontana discussed the company's strategy, noting the importance of approaching both the Centers for Medicare and Medicaid Services (CMS) and commercial payers. While acknowledging the potential challenges in establishing reimbursement, Fontana expressed confidence in the conversations ahead and did not anticipate a strict evidence requirement for reimbursement.

The approval of the Symplicity Spyral RDN system represents a significant achievement for Medtronic in addressing uncontrolled high blood pressure. The device's unique approach and potential benefits for patients underscore its importance in the cardiovascular therapeutic landscape. With commercialization on the horizon, Medtronic aims to make a positive impact on hypertension management.