A Resounding Victory: Recor Medical and Otsuka Medical Devices Secure Green Light from FDA Advisory Committee for Paradisiacal Battle Against Hypertension

A Breakthrough Emerges: Recor Medical and Otsuka Medical Devices Secure FDA Panel’s Favor for Paradisiacal Hypertension Solution

PALO ALTO, Calif.–(BUSINESS WIRE): Brace yourselves for a medical milestone as Recor Medical, Inc. (known as “Recor”) and its visionary parent, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), unveil a momentous achievement. The stage was set at the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee, where a pivotal discussion unfolded around the Paradise™ Ultrasound Renal Denervation (RDN) system. This futuristic marvel promises to recalibrate the landscape of hypertension treatment, and the outcome was nothing short of astounding.

Imagine a resounding chorus of 12 to 0 – a unanimous vote in favor of the Paradise Ultrasound RDN system’s safety. The excitement didn’t stop there. A dynamic score of 8 to 3 in favor of efficacy, with a single vote abstaining, signaled that a revolution was on the horizon. But that wasn’t all – a stunning 10 to 2 vote resonated with the belief that the Paradise system’s benefits eclipsed any potential risks.

Should the FDA’s seal of approval be granted, a new era beckons. The Paradise Ultrasound RDN system could potentially become the inaugural FDA-approved renal denervation device in the U.S., dedicated to steering patients away from the clutches of uncontrolled hypertension.

“Hypertension’s menacing grip on cardiovascular health demands a bold response. Despite our best efforts, blood pressure control remains elusive,” remarked the distinguished Dr. Ajay Kirtane, Professor of Medicine at Columbia University. As co-primary investigator in the RADIANCE Global Program exploring the Paradise system’s potential, he expressed his satisfaction at the committee’s recognition of the device’s prowess in lowering blood pressure. Through the RADIANCE Global Program, science and innovation unite to pave the way for a brighter future.

Lara Barghout, President and Chief Executive Officer of Recor Medical, echoed the sentiments of gratitude. “To the FDA and advisory committee members, your thorough assessment is deeply appreciated. We’re driven by a shared purpose – to alleviate uncontrolled hypertension’s burden,” she exclaimed. With their sights set on anticipated PMA approval, the Paradise Ultrasound RDN system stands ready to script a new chapter in healthcare.

The heart of this groundbreaking narrative? Three clinical trials housed within the RADIANCE Global Program, each a testament to progress. More than 500 patients stepped forward, seeking relief from mild-to-moderate or resistant uncontrolled hypertension. The Paradise Ultrasound RDN system isn’t just a device; it’s a promise of transformation.

Hold your breath for the final twist – the Paradise Ultrasound RDN system proudly carries the CE mark for hypertension treatment. As it blazes a trail across continents, its quest for approval continues in the United States and Japan. The future of hypertension treatment is unfolding, and the Paradise system is leading the way.

About Recor Medical, Inc.

Nestled in the heart of Palo Alto, California, emerges the visionary powerhouse, Recor Medical. An offspring of innovation under the umbrella of Otsuka Medical Devices Co., Ltd., Recor is more than a company – it’s a revolution in the making. With an unwavering focus on reshaping the landscape of hypertension management, Recor stands as a beacon of change.

Picture this: the birth of a medical marvel, the Paradise Ultrasound Renal Denervation system, a beacon of hope for those battling hypertension. This isn’t just a device – it’s a lifeline. Journeying across continents, the Paradise system carries the CE mark, a symbol of its promise. But it doesn’t stop there. In the United States and Japan, it’s a trailblazer, an investigational force that’s reshaping possibilities.

What sets Recor apart? It’s the symphony of success echoing from three independent trials. A chorus of positive outcomes has reverberated from patients with mild-to-moderate and resistant hypertension, a testament to the Paradise system’s potential. But that’s just the beginning. In the European Union and the UK, Recor has unleashed the Global Paradise System (“GPS”) Registry – a canvas of hope, a tapestry of progress. And their ambitions know no bounds; they’re set to paint this canvas across the global landscape.

Recor Medical isn’t just changing the game; they’re rewriting the rules. With innovation as their compass and determination as their driving force, they’re charting a course towards a future where hypertension bows down to progress. It’s not just a journey – it’s a transformation, one that promises relief, empowerment, and a brighter horizon.

About Otsuka Medical Devices Co., Ltd.

Unlocking the Future of Healthcare, Otsuka Medical Devices is a global trailblazer, dedicated to rewriting the script of medical care. Their canvas? Endovascular devices that transcend conventions, offering a lifeline when traditional treatments fall short. Think beyond pharmaceuticals – Otsuka Medical Devices is charting a new course towards healing.

Here’s the plot twist: Otsuka Medical Devices is the offspring of Otsuka Holdings Co., Ltd., a powerhouse in the global healthcare arena. Their presence isn’t just felt; it’s echoed on the Tokyo Stock Exchange (JP 4578), a testament to their commitment to change. The future of healthcare isn’t distant – it’s here, in the hands of innovators who dare to dream beyond the ordinary.

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