Thrombectomy devices
Prodigy Twist
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Prodigy Twist models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| TWIST5F | Length 177 cm | Not stated | Available |
| TWIST5F | — | Not stated | Available |
| TWIST6F | — | Not stated | Available |
| TWIST6F | Length 154 cm | Not stated | Available |
| TWIST8F | — | Not stated | Available |
| TWIST8F | Length 134 cm | Not stated | Available |
| TWIST8F | Length 107 cm | Not stated | Available |
| TWIST8F-S | Length 67 cm | Not stated | Available |
| TWIST8F-S | — | Not stated | Available |
FDA clearances
- 510(k) K214114 April 2022
Procedures that use thrombectomy devices
Frequently asked questions
What is Prodigy Twist used for?
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Who makes Prodigy Twist?
Prodigy Twist is made by Imperative Care, Inc.. It is listed under mechanical thrombectomy devices in our device library.
What sizes does Prodigy Twist come in?
Sizes listed for Prodigy Twist: Length: 67–177 cm. Confirm availability with the manufacturer's instructions for use.
Is Prodigy Twist MRI safe?
The FDA device database entry for Prodigy Twist does not state its MRI safety status. Check the labeling before MRI.
Is Prodigy Twist FDA cleared?
Prodigy Twist is covered by FDA submission K214114.
How do I contact a Imperative Care, Inc. sales representative?
Imperative Care, Inc. has not listed representatives on LA Vascular yet. Visit the Imperative Care, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.