Tack Endovascular System® (4F, 1.5-4.5mm) - P190027
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 Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Tack Endovascular System® (4F, 1.5-4.5mm)
PMA Applicant: Intact Vascular, Inc.
Address: 1285 Drummers Lane, Suite 200, Wayne, PA 19087
Approval Date: April 10, 2020
Approval Letter: Approval Order
What is it? The Tack Endovascular System® (4F, 1.5-4.5mm) is intended to repair a tear (dissection) in the inside lining of a blood vessel that may have occurred following a procedure (balloon angioplasty) to improve blood flow by widening a blocked or narrowed blood vessel in the leg below the knee. The Tack Endovascular System® (4F, 1.5-4.5mm) consists of four self-expanding “Tack” implants made of a nickel-titanium alloy (nitinol) and a delivery catheter system. The delivery catheter is a long, thin, tube-like device used to deliver the Tack(s) into the artery.
How does it work? First, the doctor inserts the Tack Endovascular System® (4F, 1.5-4.5mm) delivery catheter, which comes pre-loaded with four self-expanding tacks, into the leg and moves the Tack Endovascular System® (4F, 1.5-4.5mm) to the area below the knee to be treated. Then, based on the size of the tear, the doctor decides how many Tacks from the catheter to use. Next, the doctor removes the delivery catheter and the Tack(s) stay permanently implanted in the leg to allow blood to flow in the leg while the tear heals.
When is it used? The Tack Endovascular System® (4F, 1.5-4.5mm) is used to treat patients who have a tear in the blood vessels in their leg below the knee that occurred from a balloon angioplasty procedure.
What will it accomplish? The Tack Endovascular System® (4F, 1.5-4.5mm) is designed to repair tears of the inner wall of an artery in the leg below the knee that may have occurred during a balloon angioplasty procedure. In a clinical study, The Tack Endovascular System® (4F, 1.5-4.5mm) was successfully used in 224 out of 233 patients (96%) in the United States, Europe, and New Zealand. Some patients had multiple blood vessels treated. After six months, 247 out of 301 treated segments (82%) did not require additional procedures.
When should it not be used? The Tack Endovascular System® (4F, 1.5-4.5mm) should not be used in patients who:
- Have blockages in the leg artery equal to or greater than 30% after angioplasty.
- Have arteries and veins with many turns and bends (tortuous anatomy) serious enough to prevent safe introduction and passage of the device.
- Have a known allergy to nickel-titanium alloy (nitinol).
- Cannot take standard medication such as substances used to improve pictures of the inside of the body (blood thinners and contrast agents).
Additional information (including warnings, precautions, and adverse events):