Palo Alto, CA, Aug. 12, 2024 (GLOBE NEWSWIRE) — Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announced today that the Centers for Medicare and Medicaid Services (CMS) published the Final Rule for Fiscal Year 2025 Hospital Inpatient Prospective Payment Systems (IPPS), approving a New Technology Add-On Payment (NTAP) for the Paradise™ Ultrasound Renal Denervation (uRDN) system when performed in the hospital inpatient setting. Availability of the NTAP will begin on October 1, 2024, using the ICD-10-PCS billing code X051329, which is unique to renal denervation procedures involving the Paradise ultrasound system.
The NTAP program facilitates patient access to new medical technologies by granting additional payment for inpatient procedures for two to three years while CMS collects cost data. NTAP is intended to cover the majority of excess costs for new treatments and is frequently made available for medical technologies that the FDA designates as Breakthrough Devices. Having received FDA Breakthrough Device designation in December of 2020, the Paradise uRDN system also met the criteria necessary to be approved for NTAP as defined by CMS. The NTAP approved for the Paradise uRDN system provides up to an additional $14,950 in reimbursement on top of the regular Medicare Severity Diagnosis Related Group (MS-DRG) payment for an inpatient procedure.
“We greatly appreciate CMS’s support in helping Medicare beneficiaries gain access to innovative therapies like the Paradise uRDN system,” said Lara Barghout, Recor President and CEO. “Uncontrolled hypertension remains a top concern among physicians, with many patients remaining at increased risk of cardiovascular disease and adverse consequences in spite of lifestyle changes and treatment with available medications. The availability of an NTAP for the Paradise uRDN system makes it possible for physicians to provide their patients with an additional therapeutic option that can help reduce their blood pressure.”
The Paradise uRDN system received U.S. Food and Drug Administration (FDA) approval on November 7, 2023, as a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries. It was tested through Recor’s RADIANCE Global Program of three rigorous prospectively powered and sham-controlled randomized controlled clinical trials: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, along with RADIANCE-HTN SOLO and RADIANCE II, both of which studied patients with mild-to-moderate hypertension. Each trial successfully met its prespecified primary efficacy endpoint, showing statistically significant and clinically meaningful blood pressure reductions compared to a sham arm and favorable safety profiles.
About Recor Medical, Inc.
Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System (“GPS”) Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States.
http://www.recormedical.com/
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
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- CMS Approves Additional Payment for Recor Medical’s Paradise™ Ultrasound Renal Denervation System in Hospital Inpatient Cases