Symplicity Spyral Multi-Electrode Renal Denervation Catheter
by Medtronic, Inc. PMA
Active
PMA P220026
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP220026 | Date17 Nov 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Trade Name
- Symplicity Spyral™ Renal Denervation System
- Generic Name
- Ablation catheter, renal denervation
- PMA Number
- FDA Product Code
- QYI
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Symplicity Spyral Multi-Electrode Renal Denervation Catheter is an ablation catheter designed for renal denervation. It delivers radiofrequency energy to the renal arteries to reduce blood pressure in patients with uncontrolled hypertension despite lifestyle modifications and antihypertensive medications.
This catheter is supplied as a single-use device and is intended for use in interventional radiology or cardiology settings. It is regulated under FDA Premarket Approval (PMA P220026) and classified as a Class III device. Sterility and proper handling per manufacturer instructions are required before use, and it must be stored according to the provided guidelines.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary clinical purpose of the Symplicity Spyral Multi-Electrode Renal Denervation Catheter, and how does it work?
The Symplicity Spyral Multi-Electrode Renal Denervation Catheter is designed to reduce blood pressure in patients with uncontrolled hypertension who have not responded adequately to lifestyle changes and medications. It works by delivering radiofrequency energy to the renal arteries, which helps to disrupt nerve signals that contribute to elevated blood pressure.
Is this device intended for single-use or repeated use, and what are the storage requirements?
The Symplicity Spyral Multi-Electrode Renal Denervation Catheter is a single-use device, meaning it is not meant to be reused after one procedure. Proper storage must follow the manufacturer’s guidelines to maintain sterility and functionality, as sterility is required before use.
What types of medical specialties or settings are this catheter intended for, and how is it supplied?
This catheter is intended for use in interventional radiology or cardiology settings, where specialized procedures like renal denervation are performed. It is supplied as a complete single-use system, ready for immediate use in these controlled clinical environments.
What regulatory approval does the Symplicity Spyral Multi-Electrode Renal Denervation Catheter hold, and how does that affect its use?
The device holds FDA Premarket Approval (PMA P220026), confirming it meets stringent regulatory standards as a Class III medical device. This approval ensures it has been thoroughly evaluated for safety and effectiveness as an adjunctive treatment for hypertension in eligible patients, guiding its authorized use in clinical practice.