Plasma Delipidation System (PDS-2™ System) – H190001
PDS-2 Device with Major Components
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Plasma Delipidation System (PDS-2™ System)
HDE Applicant: HDL Therapeutics, Inc.
Address: 601 21st Street, Suite 300, Vero Beach, FL 32960
Approval Date: December 1, 2020
Approval Letter: Approval Order
What is it?
The Plasma Delipidation System (PDS-2™ System ) is designed to reduce plaque build-up in the coronary arteries (coronary artery atheroma) found in the plasma of adult patients with a genetic condition that causes high levels of unwanted cholesterol (homozygous familial hypercholesterolemia or (HoFH)). The PDS-2™ System includes an instrument to process and mix the patient’s plasma with a delipidation solution, which helps remove unwanted cholesterol in the patient’s plasma. HoFH is a serious and life-threatening genetic condition that causes high cholesterol. When left untreated, HoFH can lead to early and progressive heart disease.
How does it work?
The doctor collects the patient’s plasma into a sterile bag using a device that separates the plasma and blood cells (plasmapharesis device). The patient’s plasma is placed in the PDS-2™ System and is treated with a delipidation solution and then filtered and pumped into another sterile bag. The sterile bag with the plasma is brought back to the patient’s location and the plasma is placed back into the patient’s body using an infusion pump.
When is it used?
The PDS-2™ System is intended to be used to reduce coronary artery atheroma in adult patients with HoFH who are not responsive to or cannot receive any other treatment for HoFH. A patient with HoFH can only receive seven weekly sessions of plasma treatments with the PDS-2™ System.
What will it accomplish?
In a clinical study, there was probably benefit in the reduction of coronary atheroma in patients with HoFH. Among six patients, 16 plaques were evaluated before device therapy started and two weeks after the seven weekly treatments were completed. There was a reduction in parts of the plaques two weeks after treatment in 14 of the 16 (88%) plaques and a reduction in the total size of the plaque in 11 of the 16 plaques (69%).
When should it not be used?
The PDS-2™ System should not be used in the patients who have:
- An active infection with symptoms showing reduced blood flow to makor organs (sepsis)
- Unstable blood pressure
- A history of allergy to products containing heparin
- Low blood calcium level (hypocalcemia) which may worsen during treatment with the PDS-2™ System
- Hypercoagulability and can develop pain and reduced blood flow in the legs(deep venous thrombosis) or blood clots in the lung (pulmonary embolism)
- Active inflammation of the gallbladder (cholecystitis)
- Uncontrolled high blood pressure (hypertension)
- Unstable or uncontrolled insulin dependent diabetes