Medtronic (NYSE: MDT) has secured a key international milestone with the announcement that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Symplicity Spyral renal denervation (RDN) system. The decision clears the way for the minimally invasive blood pressure treatment to enter one of the most important healthcare markets in Asia.
The approval authorizes the Symplicity Spyral system for the treatment of resistant hypertension, a condition where blood pressure remains high despite multiple medications. Medtronic said it now plans to move forward with the process of obtaining insurance reimbursement in Japan, a crucial step to ensure patient access and hospital adoption.
With this regulatory win, Symplicity Spyral is now approved for commercial use in more than 75 countries worldwide, reinforcing Medtronic’s position as a global leader in RDN therapy.
Competitive timing
The PMDA decision arrives at a particularly competitive moment. Just one week prior, Recor Medical received its own Japanese approval for the Paradise ultrasound renal denervation (uRDN) system. The two companies have been locked in a years-long battle for leadership in the RDN field.
Recor claimed the spotlight in November 2023, when it became the first company to receive FDA approval for an RDN device in the U.S. Medtronic followed shortly after, gaining FDA clearance for Symplicity Spyral only weeks later. In parallel, the companies remain engaged in ongoing patent litigation concerning their respective RDN technologies.
Japan’s regulatory approval means the rivalry has now extended into Asia, where hypertension is a major public health challenge, particularly among the country’s rapidly aging population.
How Symplicity Spyral works
The Symplicity Spyral system represents a minimally invasive alternative to lifelong drug therapy for patients struggling with uncontrolled high blood pressure.
The procedure works by targeting the renal nerves—nerve fibers surrounding the kidneys that can become overactive and contribute to persistent hypertension. During the procedure:
The patient receives sedation.
A physician inserts a thin, flexible catheter through an artery leading to the kidney.
Once in place, the catheter delivers radiofrequency energy to ablate the renal nerves, reducing their overactivity.
The catheter is removed, leaving no implant behind.
By calming the renal nerves, the therapy can help lower blood pressure levels without permanent hardware or implants. For many patients, especially those with resistant hypertension, RDN offers a potential adjunct to medications and an opportunity to improve long-term cardiovascular outcomes.
Hypertension in Japan
The approval carries significant clinical importance in Japan, where hypertension is a leading cause of stroke, heart failure, and kidney disease. An aging population and lifestyle factors have contributed to rising cases of treatment-resistant hypertension, placing strain on the healthcare system.
The introduction of RDN therapies like Symplicity Spyral and Recor’s Paradise system offers new hope for patients who fail to achieve adequate control with medications alone. These devices also align with Japan’s broader health system goals of improving outcomes in chronic disease management while reducing long-term costs associated with cardiovascular complications.
Medtronic’s perspective
Jason Weidman, senior vice president and president of Medtronic’s Coronary and Renal Denervation business, emphasized the strategic importance of the approval:
“As hypertension continues to pose a growing health challenge in Japan, the demand for advanced and alternative treatment options is becoming increasingly critical, especially for Japan’s aging population. This year marks 50 years of Medtronic serving patients in Japan. The recent approval by the PMDA underscores our dedication to advancing healthcare innovation and delivering transformative therapies to those in need. We are excited to continue our momentum and leadership in the RDN space by expanding patient and physician access to the Symplicity blood pressure procedure.”
Weidman’s comments highlight Medtronic’s dual goals: to expand access for patients while also reinforcing its longstanding presence in the Japanese market, where it has been active for five decades.
Strategic significance
With the PMDA nod, Medtronic strengthens its global footprint in RDN at a time when demand is accelerating. Physicians now have access to both the Symplicity Spyral and Paradise platforms in Japan, setting the stage for direct competition that could shape treatment protocols in Asia’s second-largest economy.
For Medtronic, the approval is more than just regulatory—it’s a statement of intent to remain at the forefront of innovation in cardiovascular care, leveraging its experience, clinical evidence, and commercial scale to challenge competitors.
Competitive dynamics: Medtronic vs. Recor in Japan’s RDN market
The approval of Medtronic’s Symplicity Spyral renal denervation (RDN) system in Japan sets the stage for a new chapter in one of the most closely watched rivalries in MedTech. For years, Medtronic and Recor Medical have battled for dominance in RDN—an emerging therapy that could reshape the treatment landscape for hypertension worldwide. With both systems now cleared in Japan, the competition is shifting into one of the globe’s most strategically important cardiovascular markets.
A tale of two platforms
The two companies offer different approaches to RDN, reflecting contrasting technological philosophies:
Medtronic’s Symplicity Spyral uses radiofrequency (RF) energy delivered through a multi-electrode catheter. Its design is optimized for consistent circumferential ablation of renal nerves, with decades of RF expertise underpinning the system.
Recor’s Paradise system employs ultrasound energy (uRDN) delivered via a balloon catheter. The technology distributes ultrasound circumferentially around the renal artery, potentially enabling more uniform nerve disruption with fewer applications.
Both platforms have produced encouraging clinical results in global trials, showing meaningful reductions in blood pressure in patients with resistant hypertension. Each system has its champions among physicians, with ongoing debate about whether RF or ultrasound will prove superior in terms of efficacy, safety, and procedural simplicity.
Strategic timing in Japan
The back-to-back approvals from Japan’s PMDA—first Recor’s Paradise and then Medtronic’s Symplicity Spyral—create a rare dual-launch scenario. Physicians and hospitals in Japan now have the opportunity to evaluate both systems in real-world practice, and payors will play a central role in determining adoption through reimbursement frameworks.
Japan’s significance lies not only in its aging demographics and high burden of hypertension, but also in its role as a bellwether market for Asia. Regulatory approval here often paves the way for broader adoption across the region, from South Korea to Southeast Asia. Whichever company establishes momentum in Japan could gain a competitive edge in future Asian market expansion.
Patent battles and commercial rivalry
The Medtronic–Recor rivalry extends beyond clinical results. The two companies remain engaged in patent litigationconcerning their respective RDN systems, a reminder of how high the stakes are in securing global leadership. Patent disputes could influence future market dynamics, particularly if rulings impact commercialization strategies or licensing requirements.
Commercially, both firms are pursuing aggressive physician training and center partnerships to accelerate adoption. Medtronic benefits from its decades of presence in Japan, deep hospital relationships, and scale in cardiovascular devices. Recor, now backed by Otsuka Pharmaceutical, brings strong local credibility and resources to its commercial rollout.
The global RDN landscape
Japan’s approvals mark another inflection point in the global rollout of RDN. Since late 2023, when Recor and Medtronic became the first two companies to secure FDA approvals in the U.S., RDN has been building momentum as a legitimate fourth pillar of hypertension management, alongside lifestyle modification, pharmacological therapy, and surgery.
Industry analysts estimate the global RDN market could exceed $3–5 billion annually by 2030, driven by:
Rising prevalence of resistant hypertension.
Growing physician confidence in long-term efficacy.
Increasing payer support as cost-effectiveness data accumulates.
Patient demand for alternatives to polypharmacy and lifelong drug dependence.
Other players, including Boston Scientific and Ablative Solutions, are also advancing RDN technologies, though Medtronic and Recor remain the clear frontrunners.
Why Japan matters now
For Medtronic, Japan offers a chance to leverage its 50-year legacy in the country’s healthcare system to win early adoption. Jason Weidman’s remarks about the company’s long-standing presence highlight this advantage. By embedding Symplicity Spyral into Japan’s cardiology networks, Medtronic could counterbalance Recor’s momentum from being the first FDA-approved system in the U.S.
For Recor, the Paradise system’s recent approval in Japan validates its rapid global strategy and positions it as a credible challenger even in markets where Medtronic has historically dominated. Backing from Otsuka gives Recor additional leverage in navigating Japan’s complex reimbursement and distribution ecosystem.
The stakes ahead
The next stage of competition will hinge on three critical factors:
Clinical differentiation – Ongoing head-to-head comparisons may clarify whether RF or ultrasound achieves superior blood pressure reductions and durability.
Reimbursement success – Securing broad insurance coverage will determine how quickly RDN expands beyond academic centers into routine care.
Physician preference and workflow – Ease of use, procedure time, and safety profiles will heavily influence adoption patterns.
Whichever company succeeds in Japan will not only capture market share but also shape perceptions globally about which RDN technology should become the standard of care.
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