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."
- Considerations for Third-Party Reprocessing Of Single-Use Medical Devices - Webcast
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast