(58 days)
The Symphony Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The Symphony 16F 82cm Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony 16F 82cm Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
The Symphony™ Thrombectomy System is comprised of the following devices:
- 24F Symphony Catheter
- 24F Symphony Standard Dilator
- 24F Symphony Advance™ Long Dilator
- 24F Symphony ProHelix™
- 16F Symphony Catheter
- 16F Symphony Dilator
- 16F Symphony ProHelix™
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
The Symphony™ 16F 82cm Thrombectomy System is comprised of the following devices:
- 16F 82cm Symphony Catheter
- 16F 82cm Symphony Length Matched Dilator
- Symphony Clot Container
- TRUVIC Generator
- TRUVIC Canister
- TRUVIC Tubeset
Both Systems are designed to remove thrombus/embolus (also referred to as 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheters and the Symphony 16F 82cm Catheter target aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter.
The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus in the peripheral vasculature or pulmonary anatomy. The 16F 82cm Catheter and compatible Dilator are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of thrombus in the peripheral vasculature. The Symphony 16F 82cm Catheter and compatible Dilator are not intended for use in the pulmonary anatomy. Both the Symphony Catheters and the Symphony 16F 82cm Catheter are used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.
Here's a breakdown of the acceptance criteria and study details for the Imperative Care, Inc. Symphony™ Thrombectomy System, specifically for the expanded pulmonary embolism indication, based on the provided 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|---|
| Primary Efficacy Endpoint: | ||
| Mean Reduction in RV/LV Between Baseline and 48-Hours (assessed by CT Angiography) | Lower one-sided 97.5% confidence interval (CI) bound > 0.20 | 0.44 ± 0.42 (Mean ± SD) |
| Lower one-sided 97.5% CI for Mean: 0.36 | ||
| Met: Yes (0.36 > 0.20) | ||
| Primary Safety Endpoint: | ||
| Composite 48-Hour Major Adverse Events (MAE) Rate (all-cause major bleeding, device-related mortality, and device-related serious adverse events including clinical deterioration, pulmonary vascular injury, or cardiac injury) | Upper one-sided 97.5% CI bound |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).