Medtronic's Symplicity Spyral™ Renal Denervation System Receives NMPA Approval as Innovative Device for Hypertension Treatment

May 01, 2024 00:06 CST Updated 00:06

Medtronic

Medical Device Manufacturer

On April 30, 2024, the NMPA approved Medtronic's "Disposable Multi-Polar Renal Artery Radiofrequency Ablation Catheter" and "Renal Artery Radiofrequency Ablation Device"Innovative Product Registration Application, original text as follows:

Recently, the National Medical Products Administration approved Medtronic's innovative product registration applications for the "One-time Use Multi-pole Renal Artery Radiofrequency Ablation Catheter" and the "Renal Artery Radiofrequency Ablation Instrument."

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.

The above two products are used together, and the radiofrequency ablation instrument can transmit 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 achieveLower Patient Blood PressureThe purpose.

▲Symplicity Spyral ^TMMulti-electrode Renal Denervation Catheter

The product has passedPhysical Method to Block Sympathetic Nerve Excitation Conduction for Lowering Blood PressureCompared with traditional drug treatment methods, it can effectively avoid the influence of factors such as patient compliance and drug half-life, providing a new auxiliary treatment method for patients with refractory hypertension.

Drug Supervision and AdministrationThe department will strengthen the post-marketing supervision of the product to protect patients' safety in using medical devices.

# Medtronic Symplicity Spyral™ Offers New Approach for Hypertension Treatment

More than 1 billion people worldwide suffer from hypertension, costing healthcare systems approximately $400 billion annually. Hypertension is the leading cause of death. Globally, less than 20% of people have their blood pressure under control.

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 or Other Vascular Disease Mortality by 7%. Blood Pressure Medications Are Somewhat Effective, but Many Hypertensive Patients Do Not Take Them.

A large number of studies on medication adherence indicate that only about 50% of patients fully follow medical advice in taking their medication within a year, while 20% of patients do not take any medication at all. For patients, more therapies for hypertension are needed. A promising new approach to replace drug treatment is ——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 RegulationAbnormal renal sympathetic nerves can increase blood pressure through both afferent and efferent nerve mechanisms, and heightened sympathetic nerve excitability is an important neural mechanism in the development of hypertension.

(1) RDN blocks renal sympathetic nerves to achieve long-term blood pressure reduction.

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™ delivers targeted radiofrequency (RF) energy to the sympathetic nerves surrounding the renal arteries in a safe manner.Block the signal transmission between the brain and the sympathetic nervous system, reducing the overactive sympathetic nerve excitability in hypertensive patients, thereby achieving the effect of lowering blood pressure.

(II) Reduce Blood Pressure Around the Clock

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. Symplicity Spyral™ Renal Denervation ProcedureGood safety profile, with no device- or surgery-related safety incidents within three years, and no adverse effects on patients' renal function, it can safely and effectively reduce blood pressure in hypertensive patients.

(Image source: official website)

The Symplicity Spyral™ single catheter can ablate blood vessels with diameters ranging from 3-8mm, utilizing a spiral electrode pattern to complete ablation in all four quadrants of the main renal artery and at least two quadrants in the renal artery branches. The system is capable of ablating the aorta, accessory vessels, and branch vessels, maximizing the probability of complete denervation. It is designed for ease of use, rapid exchange, and plug-and-play functionality.

# Approved by the FDA Half a Year Ago

Review:Medtronic: RDN System Receives FDA Approval for Market Launch!

On November 17, 2023, Medtronic announced itsSimplicity Spyral Renal Denervation SystemHas received approval from the U.S. Food and Drug Administration (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.

TheThe company also conducted a patient preference study, which showed that about one-third of patients might choose intervention when the treatment lowers blood pressure and potential risks.

Results of Medtronic's clinical program were announced in August 2023 during a two-day FDA advisory panel meeting, alongside the results from Recor Medical, whose renal denervation system became the first of its kind to receive FDA approval for market release.

Actually, in 2020,Symplicity Spyral™Renal denervation has previously received the FDA's Breakthrough Device Designation. While renal denervation alone may not eliminate the need for medication, it can help lower blood pressure without adding another drug to the patient’s daily treatment regimen.

Symplicity SpyralReceived European CE Mark approval in 2013It was then put into clinical use and has now been approved and put into use in 70 countries.

Medtronic has long been committed to the development of minimally invasive technologies and believes this product could become a multi-billion-dollar business, offering hypertension treatment solutions to millions of patients worldwide and reducing their risk of heart attacks, strokes, and other serious events associated with high blood pressure.

2024 Global MedTech List：Call for Entries: Awards Recruitment

2023Global Medical TechnologyList:Global Top 100 Medical Technology Companies | Industry Contribution Award | Technological Innovation Award | Tech Innovation Award | Innovative Medical Device Award

Global Medical Technology Industry Map: International Leaders

Cardiovascular:Medtronic｜Johnson & Johnson J&JMedTech｜BD Medical｜Boston Scientific｜Edwards Lifesciences｜Abbott｜Orthopedics:Medtronic｜Johnson & Johnson J&JMedTech｜Stryker｜Smith & Nephew S&N｜Zimmer Biomet Ophthalmology:ESSILOR｜Alcon｜Carl Zeiss Medical |Topcon｜Cooper Medical Imaging:Siemens Healthineers｜Philips Medical｜GE Healthcare｜Olympus

Global Medical Technology Industry Map: Chinese Listed Companies

Global Medical Technology Industry Map: Industrial Clusters

Editor-in-Chief | Zhao Qing Reviewed by | Yi He