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The GPS II Platelet Separation Kit · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| The GPS™ II Platelet Concentrate Separation Kit | DEVICE | The GPS™ II Platelet Concentrate Separation Kit system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. |
The GPS II Platelet Separation Kit is an investigational device being studied for use in coronary heart failure. It was evaluated in a completed Phase 1 clinical trial for its effect on leg wound healing in patients undergoing coronary bypass surgery. The device is developed by Zimmer Biomet Holdings, Inc.
The GPS II Platelet Separation Kit is developed by Zimmer Biomet Holdings, Inc., a company traded on the New York Stock Exchange under the ticker symbol ZBH. The company conducted a Phase 1 clinical trial to evaluate the device's use in coronary heart failure patients.
The GPS II Platelet Separation Kit is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled study with 140 participants. The device is investigational and has not been approved by regulatory authorities.
The GPS II Platelet Separation Kit has one completed clinical trial, registered as NCT00514241. This Phase 1 study evaluated the use of the Gravitational Platelet Separation System on leg wound healing in coronary bypass surgery, enrolling 140 patients with coronary heart failure.
The GPS II Platelet Separation Kit is not FDA approved. It is an investigational device that has completed a Phase 1 clinical trial. The study, NCT00514241, was an uncontrolled trial with 140 participants, and the device remains in clinical development.