Cook Medical, a license holder of Angiotech Pharmaceutical's paclitaxel technology, has submitted its pre-market approval (PMA) application to the FDA for the company's polymer-free Zilver PTX Drug-Eluting Peripheral Stent.
Cook Medical said that PMA submission is a critical step in the product development process, giving the FDA the appropriate information to evaluate the safety and efficacy of a medical device.
Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an anti-proliferative drug, to the target lesion.
Cook Medical’s PMA submission includes data from the randomized portion of the ongoing Zilver PTX clinical trial, the largest study of its kind for the endovascular treatment of PAD in the SFA.
Reportedly, The Zilver PTX stent was CE marked in August 2009 and has been made available in Europe since September of 2009. It is the first drug-eluting stent indicated for treating PAD in the SFA, an often difficult-to-treat blood vessel in the leg.
According to Cook, the Zilver PTX stent, upon deployment, expands and holds open the artery to restore blood flow. It then delivers the drug paclitaxel to the cells in the vessel wall to reduce the risk of new blockages forming.
In a major advance over previous drug-eluting technologies, the Zilver PTX achieves targeted drug delivery without using a polymer to adhere the drug to the stent body. This eliminates the potential patient risks associated with polymer-coated devices, including clot formation and inflammation.
Rob Lyles, vice president and global leader of peripheral intervention division at Cook Medical, said: “Filing for pre-market approval with the FDA is an exciting step forward for us in bringing Zilver PTX to market in the US. Cook is committed to continually improve the efficacy and safety of our products with the overall aim of improving patient outcomes.”