On September 25, 2024, Medtronic announced with itsSymplicity Spyral RDNSelected by the US "Fortune" magazine2024 "Change the World" List。This list recognizes companies that have made significant contributions to solving global issues and driving positive social or environmental change.
Worldwide, there isMore than 1 billion peoplePatients with hypertension spend about $400 billion on the healthcare system each year. Hypertension is the leading cause of death. Globally, onlyLess than 20%The blood pressure of the individuals was controlled.A Small Reduction in Blood Pressure Has a Significant Impact on Health Outcomes. For Example, A 2mmHg Decrease in Systolic Pressure (the Upper Number) Can Reduce Stroke Mortality by 10% and Coronary Artery or Other Vascular Disease Mortality by 7%. Antihypertensive Medications Are Somewhat Effective, but Many Hypertensive Patients Do Not Take Them.A large number of studies on medication adherence have shown,Only about 50%of patients fully adhere to their medication regimen within one year, while20% of patients do not take any medication.For patients, they need more therapies for hypertension. A new approach that could potentially replace drug treatment——Renal Denervation (RDN) offers an effective alternative therapy.
Blood pressure is controlled by complex interactions of signals from multiple systems in the body (such as the nervous system, circulatory system, and endocrine system), andThe Kidneys Play a Central Role in Long-Term Blood Pressure Regulation。Abnormal renal sympathetic nerves can increase blood pressure through two mechanisms: afferent and efferent nerves. Increased sympathetic nerve excitability is an important neural mechanism causing hypertension.
# About Symplicity Spyral™
The disposable multi-pole renal artery radiofrequency ablation catheter consists of an electrode array, catheter, catheter handle, catheter connection cable, and straightening tool. The renal artery radiofrequency ablation instrument consists of a generator, remote control, power cord, and DVI-D cable.When used together, the radiofrequency ablation generator can deliver radiofrequency energy through the catheter electrode to the intima of the renal artery.Thermal Effect of Electric CurrentDeactivate the sympathetic nerves around the renal artery vessels, block the excitation conduction of the sympathetic nerves, and achieveLowering Patient Blood PressureThe purpose.- Renal Denervation for Long-term Hypertension Control
Renal denervation therapy is the most extensively studied and clinically well-evidenced interventional treatment for hypertension.As a novel interventional therapy, Medtronic's Symplicity Spyral™ canDeliver targeted radiofrequency (RF) energy to the sympathetic nerves surrounding the renal artery, to block the signal transmission between the brain and the sympathetic nervous system in a safe manner, reducing the overactive excitability of the sympathetic nerve in hypertensive patients, thereby achieving the effect of lowering blood pressure.
- Reduce Blood Pressure 24/7
Symplicity hasAll-day Hypotensive Effect, 24-hour ambulatory blood pressure is controlled and is not affected by patient behavior. During the night and early morning, when cardiovascular risk is typically highest, the blood pressure of patients who have undergone the procedure remains consistently controlled.The Symplicity Spyral™ Renal Denervation Procedure Demonstrates Strong Safety: No Device- or Procedure-Related Safety Events Within Three Years, No Adverse Impact on Patients' Renal Function, and Effectively Reduces Blood Pressure in Hypertensive Patients.The Symplicity Spyral™ single catheter can ablate blood vessels with diameters ranging from 3-8mm. Utilizing a spiral electrode pattern, it can complete ablation in all four quadrants of the main renal artery and at least two quadrants in the renal artery branches.
The system can ablate the aorta, accessory vessels, and branch vessels, maximizing the probability of complete denervation. It is designed to be user-friendly, with rapid exchange and plug-and-play functionality.
# ApprovedChina, US, Europe
On April 30, 2024, NMPA approved Medtronic."Disposable Multi-Polar Renal Artery Radiofrequency Ablation Catheter" and "Renal Artery Radiofrequency Ablation Instrument"Innovative Product Registration Application.
In 2013, Symplicity SpyralReceived European CE Mark approval,It was then put into clinical use and has been currently used in70 CountriesApproved and put into use.On November 17, 2023, Medtronic announced itsSimplicity Spyral Renal Denervation SystemHas received approval from the U.S. FDA. The company plans to immediately begin commercialization in the United States.Symplicity Spyral™The surgery uses radiofrequency energy to ablate the renal artery nerves, thereby reducing blood pressure. Medtronic's SPYRAL HTN global clinical program conducted a 10-year study involving more than 25,000 patients, including those who were taking and discontinuing antihypertensive medications.In August 2023, the results of Medtronic's clinical program were announced at a two-day FDA advisory panel meeting.Symplicity Spyral™ RDN System isThe world's first minimally invasive treatment device system for hypertension to be approved for marketing in the three major regions of the United States, the European Union, and China.According to the data from the "Report on Cardiovascular Health and Diseases in China 2021," the population with hypertension in China exceeds 245 million. Despite the availability of medications and lifestyle interventions, the control rate remains very low. The direct and indirect economic burden caused by hypertension exceeds900 billion yuan.Following approval in China, Medtronic will collaborate with professionals to establish a training system, communicate standardized operational procedures, create a comprehensive management mechanism, and promote the standardized implementation and development of RDN therapy in China.At the same time, Medtronic will collaborate with partners in the healthcare industry to build a new model and ecosystem, ushering in the "Hypertension Comprehensive Management 2.0 Era."
# List of Award-Winning Medical Device Companies
Global Surgical Robotics Industry Awards 2024
Global Medical Technology Innovation Award 2024
Global MedTech Newcomer Award 2024
Global Innovation Medical Device Award 2024
# Overseas Large Medical Device Manufacturers
#EnMajor Medical Device Manufacturers in ChinaMindray Medical｜Lepu Medical|MicroPort｜Weigao Group|United Imaging Healthcare
