| Developers: | Medtronic |
| Branches: | Pharmaceuticals, Medicine, Health Care, Hospitals, Hospitals |
Content |
Symplicity Spyral is a multi-contact catheter for ablation of renal arteries.
The device has a spiral self-opening structure allowing to act both on the renal artery trunk and on its branches. Designed to effect the radiofrequency current on the walls of the renal arteries in order to destroy the sympathetic nerve fibers accompanying the renal artery.
The Symplicity G3 generator provides safe and efficient delivery of radiofrequency energy to Symplicity Spyral catheters for controlled ablation of renal arteries.
Catheter specifications (July 2018 data):
- 4 independent electrodes
- Possible effects on the main artery and its branches
- Energy is simultaneously delivered to four quadrants in 60 seconds
- Universal size allowing ablation in vessels 3-8 mm in diameter
- Compatibility with 6 F conductor catheter
2023
Use of the hepatic denervation system in the treatment of hypertension
On 28 Nov 2023, Symplicity Spyral reported that the first patient was successfully treated with the Symplicity Spyral renal denervation system. This multi-contact catheter with spiral construction is designed specifically for the treatment of hypertensive disease.
Medtronic notes that high blood pressure is the leading cause of heart attacks and strokes, often leading to the death of patients. In the US alone, hypertension affects about 50% of adults, however, approximately 80% of these people do not control their rates. The Symplicity Spyral system can improve the quality of life of a huge number of patients suffering from hypertension.
The first Symplicity Spyral surgery was performed at the Piedmont-Atlanta Clinic by David Kandzari, MD. The procedure is approved for use as an additional therapy method for patients with hypertension in whom lifestyle changes and medical treatment do not produce the desired result. After sedation, the doctor inserts a catheter into the artery leading to the kidney. Radiofrequency energy is then supplied to suppress excessive nerve activity associated with the kidneys. The catheter is then removed. This is a minimally invasive procedure that does not require long-term recovery of the patient. In the future, the technology is expected to be applied in many countries around the world.
 | This is a great opportunity to open a new chapter in the treatment of hypertension. Traditional methods can lower blood pressure, but studies have shown that many people cannot control their condition. A new therapeutic method will help solve the problem of high blood pressure in many patients, says Kanzari.[1] |  |
The device is recognized as dangerous
On August 23, 2023, Medtronic, one of the largest manufacturers of medical devices, announced that the US Food and Drug Administration (FDA) had recognized its Symplicity Spyral Renal Denervation System (RDN) as dangerous.
The named complex is intended for the treatment of hypertension, which manifests itself in a persistent increase in blood pressure. It is estimated that almost 1 billion adults worldwide are affected by this disease. Hypertension is one of the leading causes of heart attacks and strokes. Despite affordable medical treatment and lifestyle changes, blood pressure remains uncontrolled in many patients. Renal denervation is a method of treating high blood pressure by destroying certain renal nerves with a minimally invasive procedure using a catheter. In the case of Symplicity Spyral Renal Denervation, the result is achieved by delivering radio frequency energy.
The Commission on Circulatory System Devices (CSDP) as part of the FDA concluded that the risks associated with the use of Symplicity Spyral Renal Denervation outweigh the benefits. Initially, the number of votes "for" and "against" was distributed equally - 6:6 (plus one abstention). However, the head of the commission, Dr. Richard Lange, who has the right to vote, spoke out against. As a result, the benefit/risk vote ratio was 6:7.
At the same time, the FDA recognized the effectiveness of the medical complex under consideration: in this case, the ratio of votes "for" and "against" was 7:6. It is also noted that the Symplicity Spyral Renal Denervation system is approved for use in approximately 70 countries around the world.[2]
Notes
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