Renal Denervation Market Size & Share 2026-2035

Renal Denervation Market Size

The renal denervation market was valued at USD 550 million in 2025 and is projected to reach USD 709 million in 2026, before expanding to USD 6.4 billion by 2035 at a CAGR of 27.8%.

The forecast reflects a transition from a limited number of specialist-led programs toward a broader interventional pathway for hypertension management. Market expansion depends on whether health systems can convert a large, medically managed population into appropriately selected procedural candidates while maintaining referral discipline, procedural quality, and reimbursement support.

Hypertension creates the clinical foundation for this demand. The World Health Organization estimates that approximately 1.28 billion adults worldwide have hypertension.^{[1]World Health Organization - who.int} In the United States, nearly half of adults have hypertension, indicating the scale of the population that may require more intensive management when pharmacological treatment does not achieve durable blood-pressure control.^{[2]American Heart Association - heart.org} Renal denervation does not address the whole hypertensive population; its commercial opportunity is concentrated in patients whose clinical profile, treatment history, anatomy, and willingness to undergo an invasive procedure support referral into a structured hypertension program.

The U.S. regulatory inflection point arrived in November 2023, when the Food and Drug Administration approved Medtronic's Symplicity Spyral radiofrequency system and ReCor Medical's Paradise ultrasound system.^{[3]U.S. Food and Drug Administration - fda.gov} Approval alone does not establish routine procedure volumes. It gives hospital systems a defined technology choice, but program growth still requires trained operators, multidisciplinary screening, catheterization-laboratory capacity, and payer confidence. This explains why the revenue trajectory is steep: utilization can rise rapidly once these elements are assembled, yet early adoption remains concentrated in institutions that can manage the full patient pathway.

The projected growth rate also embeds a meaningful shift in the treatment setting. As hospitals establish procedural protocols and collect post-procedure experience, demand can extend beyond the earliest academic adopters. However, the addressable market will remain constrained where reimbursement, clinical guidance, and trained intervention capacity do not advance together. The market therefore rewards platforms and providers that reduce variability in treatment planning and procedure delivery, rather than those relying only on broad hypertension prevalence.

Key Drivers

Increasing prevalence of hypertension and drug-resistant hypertension

Hypertension prevalence supplies the demand base, but resistant or difficult-to-control disease creates the more immediate clinical rationale for renal denervation. Repeated medication escalation may leave some patients with persistent blood-pressure elevation, treatment burden, or tolerability concerns. In that setting, a catheter-based intervention can be evaluated as an adjunct to medical therapy rather than as a replacement for pharmacological management.

The commercial mechanism is selective referral. As health systems formalize hypertension pathways, they can identify patients who have undergone medication optimization and whose anatomy is suitable for a renal-artery intervention. This process makes the eligible population smaller than the headline prevalence figure, but also more actionable for hospitals, device suppliers, and payers. It shifts demand from episodic device purchasing toward program development, including screening, imaging, intervention, and follow-up.

Rising awareness about minimally invasive procedures

Renal denervation benefits from its fit with catheter-based cardiovascular care. A minimally invasive procedure can be integrated into an existing interventional workflow when the institution has imaging capability, trained personnel, and a defined process for managing renal-artery access. That operational fit is important because adoption is less likely to require a wholly new care setting than a surgical therapy would.

Awareness alone does not create procedure volume. The meaningful trigger is whether clinicians can explain where denervation fits after medication review and whether referring physicians trust the selection process. Hospitals that position renal denervation within a multidisciplinary hypertension pathway are better placed to build repeatable referrals than sites that treat it as a stand-alone device procedure.

Advancements in renal denervation technologies

Technology development is broadening the number of approaches available for sympathetic-nerve modulation. Medtronic's Symplicity Spyral is a radiofrequency-based system, while ReCor's Paradise system uses ultrasound. ABLATIVE SOLUTIONS' Peregrine system represents a micro-infusion approach that delivers alcohol to the peri-adventitial space through microneedles. These mechanisms create different requirements for energy or agent delivery, procedural planning, operator training, and evidence generation.

The strategic value of innovation is not simply more device choice. Technologies that improve procedural reproducibility can lower the operational burden of building a program, particularly where hospitals are deciding whether to expand beyond a small number of expert operators. Precision-oriented approaches, including data-supported candidate evaluation and anatomy-led treatment planning, may strengthen this effect if they demonstrate a practical ability to reduce nonresponse or avoid unsuitable procedures. Research supported by the National Institutes of Health has contributed to the continuing development of patient-selection criteria for renal denervation.^{[4]National Institutes of Health - nih.gov}

Favorable clinical evidence and clearer clinical positioning

Clinical evidence has changed the market's credibility with interventionists and hypertension specialists. The FDA's 2023 approvals converted evidence generated by radiofrequency and ultrasound programs into commercial access in the United States. In Europe, the European Society of Cardiology issued supplementary guidance in March 2024 addressing renal denervation in resistant hypertension.^{[5]European Society of Cardiology - escardio.org} Together, these developments provide a more structured basis for center-level protocol development.

Evidence generation has a cumulative commercial effect. It can support physician confidence, help define candidate criteria, and give reimbursement discussions a clearer clinical frame. It also raises the competitive bar: companies must demonstrate not only that a platform can be used, but why its treatment approach can be integrated safely and consistently into an institution's hypertension pathway.

Key Restraints

Concerns about procedural safety and potential complications

Renal denervation requires arterial access and renal-artery intervention, so safety concerns remain central to referral and adoption. Potential procedural issues, including vascular injury and renal-artery complications, make pre-procedure assessment and operator technique commercially consequential. A hospital can have access to an approved system without being ready to scale its use if it lacks a disciplined process for anatomy review, medication assessment, and post-procedure follow-up.

Variation in patient response is another restraint. Blood-pressure management is affected by medication adherence, secondary causes of hypertension, renal function, and broader cardiovascular risk. If patient selection is poorly controlled, inconsistent outcomes can weaken confidence among referring physicians and payers. The restraint therefore falls most heavily on programs that seek to accelerate volume before developing a complete clinical workflow.

Reimbursement remains a linked challenge. Payment policy must account for the procedure, associated diagnostics, and care coordination, while providers need enough clarity to justify training and catheterization-laboratory capacity. In markets where noncommunicable-disease policy emphasizes hypertension control, renal denervation can align with the objective of reducing cardiovascular risk; however, policy recognition does not automatically provide coverage for a specific device procedure.

The next phase of growth will depend on translating regulatory approval into a repeatable care model. Device suppliers have an incentive to support training and standardized workflow development, while providers must protect procedure quality even as they pursue volume. Where these incentives are aligned, reimbursement discussions can be supported by actual care-pathway performance rather than by technology claims alone.

Renal Denervation Market Segment Analysis

By Technology

Radiofrequency based renal denervation generated USD 271.755 million in 2025 and represented 49.4% of the market. The segment is projected to expand at a CAGR of 29.0% through 2035. Its scale reflects the installed clinical familiarity associated with catheter-based radiofrequency treatment and the commercial relevance of the Symplicity Spyral platform following FDA approval. Radiofrequency remains the leading technology because a growing operator base can incorporate it into established interventional practice, not merely because it was an earlier entrant.

Ultrasound based systems accounted for USD 145.107 million, or 26.4%, of 2025 revenue and are forecast to grow at a CAGR of 28.3%. The Paradise ultrasound renal denervation system is designed to deliver circumferential treatment from within the renal artery. Its commercial proposition rests on an alternative procedural mechanism and a distinct evidence base. The resulting competition is not simply price-based: hospitals will assess platform fit against operator experience, treatment workflow, evidence requirements, and procurement strategy.

Micro-infusion based technologies reached USD 99.639 million in 2025, equivalent to an 18.1% share, and are expected to grow at a CAGR of 26.9%. The Peregrine system's alcohol-mediated approach differs from thermal-energy platforms by targeting peri-adventitial nerves through microinfusion.^{[6]ABLATIVE SOLUTIONS - ablativesolutions.com} This segment's opportunity is tied to whether nonthermal delivery can establish a differentiated role in selected anatomical or clinical circumstances. Its growth outlook is strong, but slightly below radiofrequency and ultrasound, reflecting the need for continued clinical and regulatory maturation.

Other technologies generated USD 33.499 million and held 6.1% of revenue in 2025. Their 9.2% CAGR indicates that the market is expected to concentrate around better-established radiofrequency, ultrasound, and micro-infusion approaches. This does not eliminate innovation opportunity; it raises the evidence threshold for systems seeking to displace platforms that already have defined commercial pathways.

By Application

Hypertension was the largest application, generating USD 377.981 million in 2025, or approximately 68.7% of total revenue. The segment is expected to grow at a CAGR of 29.2%. This concentration is consistent with the approved and clinically established use case: controlling blood pressure in appropriately selected patients when medical management alone has not delivered sufficient results. The global burden of hypertension gives this segment depth, while regulatory approvals and clinical guidance make it the clearest route to near-term procedure growth.

Chronic kidney disease generated USD 122.921 million in 2025 and represented approximately 22.3% of the market. It is forecast to advance at a CAGR of 25.6%. Its importance lies in the interaction between renal disease, hypertension, and sympathetic activity, but the application remains more dependent on indication development and supporting evidence than the core hypertension segment. Commercial expectations should therefore distinguish investigational potential from routine clinical adoption.

Other applications accounted for USD 49.098 million, or approximately 8.9%, of 2025 revenue, and are projected to grow at a CAGR of 18.7%. This category includes emerging cardiovascular and metabolic applications. It provides longer-term option value for the market, but its lower growth rate reflects the uncertainty surrounding evidence requirements, regulatory pathways, and payer acceptance beyond hypertension and chronic kidney disease.

By End Use

Hospitals represented USD 346.241 million in 2025, or 63.0% of market revenue, and are projected to grow at a CAGR of 29.0%. Their position reflects the need for catheterization capability, multidisciplinary clinical support, and post-procedure management. Hospitals can coordinate hypertension specialists, interventionalists, nephrology teams, imaging, and follow-up within one governance structure, which makes them the central setting for initial program scaling.

Ambulatory surgical centers generated USD 138.322 million in 2025 and held 25.1% of revenue. The segment is expected to expand at a CAGR of 26.3%. Growth depends on the ability to transfer carefully selected procedures from hospital settings without weakening access to clinical assessment or escalation capacity. The slower growth rate relative to hospitals reflects the continued importance of patient complexity, payer design, and procedural infrastructure.

Specialty clinics accounted for USD 65.437 million in 2025, or 11.9% of the market, and are forecast to grow at a CAGR of 23.5%. Their strongest role is likely to be in identification, medication review, risk assessment, and follow-up rather than broad independent procedure delivery. Clinics connected to hospital intervention programs can become valuable access points by improving referral quality and reducing the friction between diagnosis and treatment.

Application and end-use patterns reinforce this point. Hypertension remains the market's commercial anchor because it has the clearest regulatory and care-pathway foundation. Chronic kidney disease and other applications expand the addressable opportunity, but they should be treated as evidence-dependent extensions rather than immediate substitutes for the core indication. Hospitals retain the largest revenue pool because they can manage complexity; outpatient settings will gain relevance only where patient selection and reimbursement permit a safe transfer of care.

Renal Denervation Market Regional Analysis

North America

North America generated USD 213.555 million in 2025 and accounted for 38.8% of the global market. The region is projected to grow at a CAGR of 26.9%. U.S. FDA approval of radiofrequency and ultrasound systems in November 2023 gave North American providers a defined regulatory foundation for commercial program development. The U.S. represented USD 198.953 million of regional revenue in 2025 and is projected to grow at a CAGR of 26.4%, while Canada accounted for USD 14.602 million and is expected to grow faster at a CAGR of 32.3%. The U.S. remains the regional scale market; Canada's higher percentage growth reflects a smaller base and potential for later-stage program expansion.

In the U.S., the commercial pathway is now defined by FDA-approved radiofrequency and ultrasound systems, but procedure growth remains tied to hospital-led screening, operator training, and payer adoption. The country's scale makes it the principal North American setting in which post-approval utilization can establish the operational evidence needed to support wider referral.

Canada's smaller 2025 market and faster forecast growth indicate an earlier commercial development stage. Its progression depends on converting regulatory and clinical interest into access at specialized cardiovascular centers, where a concentrated provider base can support controlled program rollout before broader diffusion.

Europe

Europe represented USD 165.703 million in 2025, equivalent to 30.1% of global revenue, and is forecast to advance at a CAGR of 27.2%. Germany, the UK, France, Spain, Italy, and the Netherlands form the core regional market set. European growth benefits from an established hypertension-specialist environment and clinical guidance that places renal denervation within structured evaluation for resistant hypertension. The practical constraint is variation in country-level reimbursement and provider capacity, which can produce uneven adoption across otherwise comparable health systems.

Germany

Germany has established a comparatively formal implementation environment. The German Cardiac Society's 2024 center-certification standards, national hypertension-guideline inclusion, and DRG reimbursement pathway create a clearer route for certified centers to make renal denervation a routine part of specialist care.

United Kingdom

In the UK, NICE HealthTech guidance HTG662 limits renal denervation to special arrangements for clinical governance, consent, audit, or research. A UK cost-effectiveness analysis of radiofrequency renal denervation reported an incremental cost-effectiveness ratio of £13,482 per quality-adjusted life-year, below NICE's cited threshold range, but governance requirements continue to limit rapid routine adoption. NICE's March 2025 IPG801 guidance also addresses alcohol-mediated perivascular renal denervation.

France

France has combined reimbursement activity with detailed clinical selection criteria. HAS granted transitional reimbursement for Symplicity Spyral in November 2023, while a 2024 multi-society consensus defined eligibility around resistant hypertension, renal function, and multidisciplinary validation at expert centers.

Spain

Spain's market development is driven by structured professional and health-technology-assessment activity rather than broad procedural diffusion. A joint SEH-LELHA and ACI-SEC statement places the procedure within specialized hypertension and interventional cardiology teams, while AVALIA-T published a 2024 assessment of renal sympathetic denervation for resistant hypertension.

Italy

Italy's GISE and SIIA 2024 position paper identifies renal denervation as an option for difficult-to-treat hypertension alongside lifestyle and pharmacological management. The requirement for certified third-level reference centers is likely to concentrate procedures in experienced institutions during the early adoption period. Netherlands

The Netherlands has a long-standing national renal denervation registry that collects standardized baseline, safety, and outcome information across participating centers. Dutch expert guidance positions denervation as an adjunct for uncontrolled hypertension or intolerance to multiple antihypertensive classes, and European economic analyses have identified ultrasound renal denervation as potentially cost-effective in the Netherlands under specified assumptions.

Asia Pacific

Asia Pacific generated USD 126.700 million in 2025 and held 23.0% of the market. It is the fastest-growing region, with a projected CAGR of 29.8%. China, Japan, India, Australia, and South Korea combine large hypertension populations with developing interventional-care infrastructure. Commercial access in the region will be shaped by local regulatory requirements, distributor capability, hospital procurement models, and the ability to establish specialist referral pathways. The region's high growth rate reflects substantial headroom, but it should not be interpreted as uniform readiness across all countries.

China

China has the region's largest immediate clinical base: 271.5 million adults aged 30–79 have hypertension, while only 21% have controlled blood pressure. SyMap Medical received NMPA Class III approval for its msRDN mapping and selective-ablation system in August 2024, providing a domestically approved procedural option supported by the SMART trial at major metropolitan hospitals. The combination of high unmet need and local regulatory access gives China a distinctive pathway, although referral, affordability, and hospital implementation will govern realized volume.

Japan

Japan has moved rapidly from device approval to reimbursement. The PMDA approved Paradise ultrasound renal denervation in August 2025 and Symplicity Spyral in September 2025. Japan's National Health Insurance began covering Paradise from March 1, 2026, with commercial sales commencing the following day. The Japanese Society of Hypertension's 2025 Class II, Level B recommendation for resistant hypertension strengthens the clinical basis for implementation.

India

India has an estimated 220 million people with hypertension, yet only 12% have controlled blood pressure. A 2025 pooled analysis placed hypertension prevalence at 27.2%, with substantial regional variation. This gap creates a large potential demand base, but renal denervation adoption will depend on how quickly specialized interventional centers, referral protocols, and affordability mechanisms develop.

Australia

Australia is in a formal health-technology-assessment phase rather than a confirmed reimbursement phase. MSAC application No. 1659 covers catheter-based renal denervation for patients with uncontrolled systolic blood pressure despite multiple therapies or medication intolerance, providing a route for evidence review and public consultation. The absence of a confirmed listing means commercial uptake remains contingent on the outcome of that process.

South Korea

South Korea has both domestic device-regulatory activity and emerging innovation programs. The MFDS approved an ultrasound-based renal denervation device for adjunctive blood-pressure lowering, with cited clinical evidence showing a greater systolic-pressure reduction than control. Separately, Seoul-based DeepQure received FDA IDE approval in June 2024 for its extravascular HyperQure system, indicating that Korean developers are participating in next-generation renal-denervation development.

Latin America

Latin America accounted for USD 26.179 million in 2025, or 4.8% of global revenue, and is projected to grow at a CAGR of 28.1%. Brazil, Mexico, and Argentina provide the relevant market hierarchy. Growth will depend on expansion of interventional cardiology capacity and the extent to which public and private payers recognize the procedure within broader hypertension and cardiovascular-care priorities.

Brazil

Brazil has a substantial cardiovascular burden, with 388,908 cardiovascular deaths reported for 2024 and high hypertension prevalence. Its established cardiovascular-care infrastructure and Hiperdia program provide a foundation for specialist hypertension management, although only 33.0% of hypertensive patients were reported to achieve therapeutic targets. Renal denervation is therefore most likely to emerge initially through high-capability centers managing persistent control gaps.

Mexico

Mexico combines a national cardiovascular action-plan context with a material treatment gap. A pooled analysis reported hypertension prevalence of 24.1%, with 59.9% awareness, 50.0% treatment, and 49.9% control. The World Heart Federation reported 199,215 cardiovascular deaths in 2024. These conditions support the clinical rationale for intervention, but access will depend on financing and specialist-center capacity.

Argentina

Argentina has a more explicit professional and assessment framework. The Argentine Cardiology Society's 2024 guidance recommends renal denervation for resistant hypertension and for uncontrolled hypertension on extensive therapy in specialized multidisciplinary centers. A January 2025 rapid assessment from IECS identified factors favorable to the procedure, signaling a structured evaluation environment rather than automatic coverage.

Middle East and Africa

Middle East and Africa generated USD 17.863 million in 2025 and represented 3.2% of global revenue. The region is expected to grow at a CAGR of 27.6%. South Africa, Saudi Arabia, and the UAE are the priority countries in the regional scope. Adoption is likely to begin in tertiary centers with advanced cardiovascular infrastructure, then widen only if regulatory pathways, training, and funding arrangements support sustained procedure programs.

South Africa

South Africa has high hypertension prevalence, estimated at 40%–50% of adults, with control rates below 50%. A South African Global SYMPLICITY Registry cohort recorded office systolic-pressure reduction of 16.9 mmHg at 12 months, although renal denervation remains available mainly through private-sector prospective studies. This creates an evidence-supported but access-constrained market.

Saudi Arabia

Saudi Arabia's hypertension prevalence differs materially between nationals and expatriates, and cited blood-pressure-control rates range from 37% to 45%. The 2023 NHC/SHA guidance states that renal denervation may be considered for treatment-resistant or high-cardiovascular-risk uncontrolled hypertension, establishing a clinical opening that still requires center-level capability and funding alignment.

UAE

The UAE combines a high reported hypertension burden with advanced tertiary care. A pooled estimate placed prevalence at 31%, while World Heart Federation data reported an age-standardized prevalence of 43.9%. Cleveland Clinic Abu Dhabi's complex cardiovascular-intervention capacity provides a potential anchor for specialist programs, but wider adoption depends on formal referral and payment pathways.

Asia Pacific offers the highest forecast growth because hypertension burden and market headroom are substantial, but commercial execution will be country-specific. Suppliers entering the region must align regulatory strategy, local clinical education, and hospital procurement support rather than treating the region as one market. Latin America and Middle East and Africa represent longer-horizon expansion opportunities in which tertiary-center concentration and funding availability will remain decisive.

Renal Denervation Market Share & Competitive Landscape

Competition in renal denervation is centered on platform mechanism, clinical evidence, regulatory access, and the capacity to help providers establish safe, repeatable programs. The authorized company scope comprises Abbott, ABLATIVE SOLUTIONS, Boston Scientific, Johnson & Johnson, Medtronic, Mercator MedSystems, Otsuka, Recor, SyMap Medical, Symple Surgical, TERUMO, and VENUS MEDTECH.

Medtronic competes through the Symplicity Spyral radiofrequency renal denervation system, which received FDA approval in 2023. Its position is supported by the commercial relevance of a radiofrequency platform in a market where clinician familiarity and training infrastructure can influence hospital purchasing decisions.

Otsuka and Recor are associated with the Paradise ultrasound renal denervation system. Otsuka's November 2023 announcement described the U.S. approval of Paradise and positioned renal denervation within its hypertension-related development activity. The platform provides a distinct ultrasound-based alternative to radiofrequency treatment, making mechanism-specific evidence and procedural workflow important sources of differentiation.

ABLATIVE SOLUTIONS is developing the Peregrine system, a micro-infusion catheter designed to deliver dehydrated alcohol to the peri-adventitial space of the renal artery. Its competitive relevance lies in offering a nonthermal denervation approach. The company's ability to secure a meaningful position will depend on how its evidence and operating requirements compare with established energy-based platforms.

Boston Scientific's Vessix technology provides a radiofrequency-based competitive reference point within the category. TERUMO markets the Iberis renal denervation system, demonstrating the importance of regional device portfolios and local commercialization pathways. Competitive advantage in Asia Pacific and other emerging markets may depend less on global scale alone than on regulatory execution, provider relationships, and the ability to support training at early adopter centers.

Johnson & Johnson operates in the renal denervation space through its MedTech cardiovascular portfolio, with historical activity including CE Mark authorization for catheter-based renal denervation technologies. Its broad interventional cardiology infrastructure and established hospital relationships provide commercial leverage relevant to the RDN category should its pipeline priorities align with the market's continued growth.

Abbott's strategic relevance lies in cardiovascular ablation capability rather than an active renal denervation product. Its electrophysiology business grew through pulsed-field-ablation activity in 2025, including the Volt PFA system, while no renal-denervation product or disclosed pipeline program was identified. Its catheter-based energy-delivery expertise and hospital procurement relationships make Abbott a credible potential entrant if renal denervation reaches a scale compatible with its cardiovascular-portfolio priorities.

Mercator MedSystems brings an adventitial drug-delivery capability that is relevant to chemical denervation. Its FDA-cleared and CE-marked Bullfrog Micro-Infusion Device can deliver therapeutic agents into adventitial and perivascular tissue surrounding renal arteries, and the company cites preclinical renal-denervation work using ethanol and guanethidine-based compounds. This positions Mercator as a delivery-technology participant that could complement a larger cardiovascular-device portfolio rather than as a direct thermal-platform competitor.

SyMap Medical occupies a differentiated position in China through its msRDN system, which maps renal sympathetic-nerve hotspots before selective ablation. Its August 2024 NMPA Class III approval, together with the system's electrical-stimulation mapping and temperature-controlled ablation functions, gives SyMap a feedback-led alternative to fixed-energy approaches. The company's regulatory position and links to major Chinese academic hospitals provide a potential first-mover advantage in a large domestic hypertension market.

Symple Surgical is developing the DirectAblate Renal Denervation System, a microwave-based catheter designed for circumferential, non-contact ablation. The system incorporates arterial-wall cooling and real-time surface-temperature monitoring, with a design objective of a single 90-second treatment per renal artery; safety and effectiveness in humans remain under investigation. Its relevance is therefore tied to future procedural simplification, particularly if it can reduce the technical barriers that currently concentrate treatment in high-volume centers.

VENUS MEDTECH conducts renal-denervation development through Renaly Ltd., a joint venture formed with Healium Medical in June 2021 to develop ultrasound-based devices. Venus Medtech controls Renaly and continues to list renal denervation within its broader cardiovascular-intervention pipeline.Its competitive relevance will depend on the pace at which the joint venture translates pipeline activity into clinical and regulatory progress in China and international markets.

Recent Industry Developments

• March 2026: Otsuka Medical Devices and Otsuka Pharmaceutical announced Japan National Health Insurance coverage for the Paradise uRDN system, effective March 1, 2026, with commercial sales commencing March 2, 2026.

• October 2025: Final three-year SPYRAL HTN-ON MED results presented at TCT 2025 reported sustained 18 mmHg office-based systolic blood-pressure reductions; the corresponding analysis was subsequently published in the Journal of the American Heart Association.

• September 2025: Medtronic received PMDA manufacturing and marketing approval for the Symplicity Spyral renal denervation system in Japan on September 2, 2025, enabling the company to initiate the insurance-coverage process.

• August 2025: Otsuka Medical Devices received PMDA manufacturing and marketing approval for the Paradise ultrasound renal denervation system on August 25, 2025, the first approval in Japan for a medical device indicated for resistant hypertension; post-marketing surveillance is planned.

• August 2024: SyMap Medical received NMPA Class III Medical Device approval for its msRDN system, SyMapCath I and SYMPIONEER S1, on August 6, 2024. The system is indicated as an adjunctive treatment for drug-resistant hypertension.

• March 2024: The European Society of Cardiology issued supplementary guidance addressing renal denervation in resistant hypertension.

• November 2023: The U.S. Food and Drug Administration approved Medtronic's Symplicity Spyral radiofrequency renal denervation system and Recor Medical's Paradise ultrasound renal denervation system.