Irish medical device company Medtronic has received China’s National Medical Products Administration (NMPA) approval for its Symplicity Spyral renal denervation (RDN) system.
Also known as the Symplicity blood pressure procedure, Symplicity Spyral is the first RDN system to receive regulatory approval in China.
It is an advanced, minimally invasive procedure that delivers radiofrequency energy to soothe the nerves near the kidneys that can become overactive and cause elevated blood pressure.
The NMPA approval follows the US Food and Drug Administration (FDA) approval of the Symplicity Spyral system and its launch in India and Canada.
Also, the Symplicity Spyral system recently received approval under the Greater Bay Area policy in China to commercialise the system to hospitals in the Greater Bay Area.
The company plans to continue with the provincial registration process, with plans to begin sales of Symplicity Spyral in China in the short term.
Medtronic senior vice president and coronary and renal denervation business president Jason Weidman said: “As the leader in renal denervation, we are looking forward to bringing the Symplicity blood pressure procedure to China, where high blood pressure rates continue to increase.
“As these rates continue to climb, the need for innovative, alternative treatments is strong. The Symplicity procedure can provide people in China with another potential option when seeking high blood pressure solutions, complementing lifestyle modifications and medication.”
According to Medtronic, Hypertension is one of the most common public health challenges in China, with more than 245 million people affected by the condition.
Also, only 13.8% of people living with hypertension in China have their condition under control, and an adjunctive treatment option may help patients better manage their blood pressure.
The data showed that small blood pressure reductions significantly reduce cardiovascular risk, whereas a 10mmHg decrease in blood pressure leads to a 20% risk reduction of major cardiovascular events.
Medtronic said that Symplicity Spyral is one of the most thoroughly tested cardiovascular interventional devices and is backed by experience with more than 25,000 patients worldwide.
The procedure reduced patients’ 9mmHg office-based systolic blood pressure (OSBP) at three months, 9.9mmHg at six months, and 18mmHg at three years.
Symplicity also improved blood pressure control with considerably more time in treatment range after radiofrequency RDN, when compared to sham through three years.
Furthermore, the Symplicity blood pressure procedure is currently limited to investigational use in Japan and is approved for commercial use in more than 70 countries around the world.
