Cook Medical released 2 favorable studies supporting the use of its Zilver PTX stent in the treatment of peripheral artery disease.
Results from both studies were presented this week at the Vascular Interventional Advances 2014 meeting in Las Vegas.
Cook said a 5-year study tracking 479 patients showed that blocked blood vessels treated with Zilver PTX stents remained unblocked significantly longer than those treated with balloon angioplasty or provisional bare metal stents. Zilver PTX stents are coated with the drug paclitaxel, which helps discourage the formation of blockages.
“At 5 years, Zilver PTX demonstrated a 48% reduction in reintervention and a 41% reduction in restenosis compared to standard care,” said Dr. Michael Drake, who presented the results at the medical meeting on Nov. 4. “Five-year data for Zilver PTX versus bare-metal stenting confirm a sustained benefit for the paclitaxel-eluting stent. Zilver PTX continues to show benefit through 5 years with no late catch-up.”
Cook also unveiled a 12-month post-market study in Japan confirming Zilver PTX’s effectiveness in treating a wide variety of blood-vessel lesions in patients with PAD.
The study tracked approximately 800 Japanese patients who received Zilver PTX stents to treat blood vessel lesions, some of which were quite severe, in their legs. After 12 months, 91.4% of the patients still did not require revascularization.
“We’re very pleased with the data from the Japan PMS study because the study included a broad range of lesion types and lengths similar to what doctors treat on a daily basis. Like our other studies, this evaluation shows that for most patients there is an enduring drug effect from Zilver PTX a year after implantation,” peripheral interventions head Mark Breedlove said in prepared remarks.
Zilver PTX was approved for the treatment of PAD in Europe in 2009. It received regulatory approval in the U.S. and Japan in 2012.
In April 2013, Cook issued a worldwide recall for Zilver PTX after receiving reports of 1 patient death and 1 injury possibly associated with breakage in the catheter delivery system. The product was put back on the market in July of that year.
In August, Cook announced it had begun enrollment for a clinical study of the product in China.
Last month, the FDA released a warning letter it had recently sent Cook over problems found during inspections of a Bloomington, Ind., plant last summer.
The inspections turned up issues with how Cook accounts for products that are scrapped during the manufacturing process, according to the letter. The plant makes vascular implants, intravascular catheters and related systems.
