Medtronic announced it has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its Symplicity Spyral renal denervation (RDN) system to treat resistant hypertension. The company will now initiate the process to obtain approval for insurance coverage in Japan, where hypertension affects approximately 43 million adults.
The approval addresses a significant unmet medical need in Japan's healthcare system. Despite widespread awareness of hypertension, only about 60% of those diagnosed with high blood pressure receive treatment, and just under half of those treated achieve adequate blood pressure control. These statistics highlight the ongoing need for accessible and innovative interventions that can complement medication and lifestyle modifications.
Minimally Invasive Procedure Technology
The Symplicity blood pressure procedure represents an innovative, minimally invasive approach to treating resistant hypertension. The procedure uses a single thin catheter to deliver radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure.
During the procedure, after sedation, the doctor inserts a catheter into the artery leading to the kidney. Once positioned, the system administers energy to calm the excessive activity of the nerves connected to the kidney. The device is then removed, leaving no permanent implant behind.
Clinical Evidence and Global Experience
Medtronic's clinical trials have demonstrated significant efficacy for the renal denervation system. The SPYRAL HTN-ON MED study showed a 24-month office systolic blood pressure reduction of 17.4 mmHg in Spyral patients through two years, with significantly greater reduction versus sham treatment.
The SPYRAL HTN clinical program represents the most comprehensive clinical program studying RDN, involving more than 5,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The program is backed by experience in over 30,000 patients globally and includes the longest and largest real-world registry, along with the largest dataset showing long-term reductions without the need for additional medication.
Strategic Significance for Aging Population
"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," stated Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic.
The approval marks a significant milestone for Medtronic's 50-year presence in Japan. "The recent approval by the PMDA underscores our dedication to advancing healthcare innovation and delivering transformative therapies to those in need," Weidman added.
Global Market Expansion
The Japanese approval follows recent regulatory successes in other major markets. The Symplicity Spyral system is now approved for commercial use in over 75 countries around the world. Recent approvals include clearance from the US Food and Drug Administration, as well as launches in India and Canada.
In China, Medtronic has also received approval from the National Medical Products Administration (NMPA) for the Symplicity Spyral system, making it the first RDN system to receive NMPA approval in China. The Chinese market presents a substantial opportunity, with over 245 million people affected by hypertension and only 13.8% of those living with the condition having it under control.
