Cook Medical, a healthcare device manufacturer based in Bloomington, Indiana, recently received premarket approval (PMA) from the United States Food and Drug Administration (FDA) for its Zilver PTX stent. The Zilver PTX stent is the first drug-eluting stent for peripheral artery disease that has received approval in the U.S.
The PMA for the device comes approximately one year after the Circulatory Systems Devices Panel at the FDA recommended the device for approval. The Zilver PTX stent is a drug-eluting, self-expanding stent that comes coated in a layer of paclitaxel, a mitotic inhibitor used in chemotherapy.
In a prepared statement, Cook Medical VP Rob Lyles said, "This approval marks the start of Cook's program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries." He continued, "We expect to have a full suite of drug-eluting peripheral stents in the most commonly used lengths and diameters available to U.S. physicians."
- Making Quality More Predictable: What You Need to Know about Your Medical Device Manufacturer - Webcast
- 3D Printing for Surgical Devices and Medical Models - Webcast
- The Power of Extractable/Leachable Chemistry Testing for Medical Devices - Webcast
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast