The FDA has approved Cook Medical’s Zilver® PTX®, the first drug-eluting stent (DES) for treating peripheral arterial disease (PAD) in the above-the-knee femoropopliteal arteries. This is a new approach to treating PAD, and Cook Medical is the only manufacturer with a drug-eluting stent that has been shown to inhibit re-narrowing of arteries in the SFA by 50 percent. The key differentiator is the drug paclitaxel. This new treatment is going to change the way physicians treat PAD.
The stent has been approved in Europe already. In addition another article of interest was an interview I did a while back with UCLA Dr. Peter F. Lawrence, Director of the UCLA Gonda Vascular Center who treats patients for PAD. BD
The UCLA Gonda Vascular Center Treats PAD (Peripheral Arterial Disease)-Interview with Dr. Peter Lawrence Chief of Vascular Surgery
Also a while back I spoke with Rob Lyles at Cook Medical where we talked about PAD the at the time the up and coming Zilver stent. These have to be a bit more rugged as the leg moves versus a stationary muscle like the heart for example.
I did this interview way back when the Medical Quack was still fairly new and updates on the Zilver stent as they came along and I am guessing this is about 3 years worth of writing about the stent until the FDA approval was given today. It makes you stop and think of all the time and expense needed today to bring a well needed product to market. BD
BLOOMINGTON, Ind.--(Cook Medical has received U.S. Food and Drug Administration (FDA) marketing approval for the first devices in its Zilver® PTX® Drug-Eluting Peripheral Stent portfolio, company officials reported today. It’s the first time the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery.)--
“Drug-eluting stents such as Zilver PTX will move quickly, in my opinion, to become the standard of care for PAD patients worldwide.”
“This approval marks the start of Cook’s program to bring the benefits of drug elution to U.S. physicians treating the peripheral arteries,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “No other company can match Cook’s commitment to this technology, and by the end of 2013, 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.”
The Zilver PTX Drug-Eluting Stent is intended to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA).
In order to supply as many physicians as possible with this new technology, Cook is making Zilver PTX available initially in 80 mm lengths in 6 mm and 7 mm diameters. The products indications for use also allow two Zilver PTX 80 mm stents to be overlapped to treat longer lesions up to 140 mm. The FDA approval also includes 40 mm and 60 mm lengths, which will be introduced to the U.S. early in 2013. Cook expects to receive regulatory approval for 120 mm length stents in both diameters next year.
Data from Cook’s pivotal clinical trial indicate:
Eight out of ten patients treated with Zilver PTX still had open arteries (primary patency) after one year1. That compares to only 3 out of 10 patients treated with angioplasty alone.
Patients who received a bare metal stent required more than twice as many reintervention procedures to reopen the SFA as patients who received Zilver PTX. 2