Medtronic has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted reimbursement approval for the Symplicity Spyral renal denervation system for the treatment of resistant hypertension.
“This decision enables broader access to a therapy that has been shown to provide sustained reductions in blood pressure and improve outcomes for patients with hypertension,” said Jason Weidman, senior vice president and president, Coronary & Renal Denervation, Medtronic. “We are proud to continue our 50-year legacy of serving patients in Japan through innovation and collaboration.”
The Symplicity blood pressure procedure is a catheter-based procedure to deliver radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure.
Medtronic clinical trials, including the SPYRAL HTN-ON MED study, showed 24-month office systolic blood pressure reduction of 17.4mmHg (Spyral patients) through two years and significantly greater reduction versus sham. The SPYRAL HTN clinical programme has the longest and largest real-world registry and the largest dataset showing long-term reductions without the need for additional medication.
The Medtronic SPYRAL HTN global clinical programme is the most comprehensive clinical program studying renal denervation in more than 5,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk, and is backed by experience in over 30,000 patients globally.
The Symplicity Spyral renal denervation system is approved for commercial use nearly 80 countries around the world.
