FDA has granted breakthrough therapy device designation to two renal artery denervation systems in quick succession. ReCor Medical and SoniVie disclosed the FDA actions within one day of each other as the agency continued to award regulatory privileges to device developers in the closing weeks of 2020.
SoniVie was the first of the device developers to disclose the receipt of a breakthrough designation. FDA granted the status to the Israeli-based SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for use in the treatment of resistant hypertension, defined as the persistence of high blood pressure despite the use of three classes of antihypertensive medication.
TIVUS uses high-frequency non-focused ultrasound to ablate nerves in the renal artery. In doing so, the device is designed to reduce nerve activity and, by extension, lower blood pressure. Cardiosonic, the original developer of the technology, linked TIVUS to mean reductions in systolic and diastolic office blood pressure at six months of 30.6 and 14.1 mm Hg, respectively, in a small trial.
Cardiosonic received a CE mark for the device in 2014 and outlined plans to use it in the treatment of resistant hypertension. SoniVie originally licensed the device for use in the treatment of pulmonary arterial hypertension and picked up a breakthrough designation in that indication last year. Now, SoniVie has licensed the remaining intellectual property from Cardiosonic.
If SoniVie brings TIVUS to the U.S. market, it may face competition from ReCor Medical, a subsidiary of Otsuka Medical Devices. The day after SoniVie shared its update, ReCor revealed FDA has awarded breakthrough status to its ultrasound renal denervation system for use in the treatment of patients with persistently high blood pressure.
The Paradise Renal Denervation System is designed to treat overactive nerves leading to the kidneys. ReCor shared news of the breakthrough designation alongside new data on its approach. Patients were randomized to undergo treatment with Paradise or a sham procedure on top of receiving three antihypertensive medications. ReCor said the daytime blood pressure in the Paradise group fell in the two months after treatment, causing the study to hit its primary endpoint.
SoniVie and ReCor are targeting a market that Medtronic has pursued for years. After failing a key trial in 2014, Medtronic regrouped and this year presented clinical data suggesting its device drives sustained reductions in blood pressure in multi-drug resistant hypertensive patients.
The renal denervation breakthrough designations are part of a bigger batch of recent updates on the FDA program. Vectorious Medical Technologies received the designation for its V-LAP system, which consists of an implantable sensor that monitors left atrial pressure. The device is designed to equip physicians to monitor patients remotely, potentially enabling them to detect signs of worsening heart condition in between periodic face-to-face checkups.
FDA has also recently awarded breakthrough statuses to companies operating outside of the heart disease sector. Carlsmed claimed to have achieved a regulatory first when FDA granted breakthrough status and 510(k) clearance to its so-called aprevo devices. The implants are cleared for use in the correction of adult spinal deformity.
SFC Fluidics received breakthrough status for a device that subcutaneously delivers insulin at set and variable rates. FDA also granted the status to Fujifilm’s endoscopic light and image processing technology, which the company claims will enhance visualization in therapeutic procedures. ReGelTec secured the designation for a hydrogel treatment for chronic low back pain.