News | March 06, 2012

Cook Medical Receives Japanese Approval for Zilver PTX Drug-Eluting Stent

March 6, 2012 — In a development that brings advanced combination therapy treatment of peripheral artery disease (PAD) to Japanese patients for the first time, Cook Medical has received PMDA approval to sell the Zilver PTX Drug-Eluting Peripheral Stent in Japan. The device, indicated for treating PAD in the superficial femoral artery (SFA), is the first stent available in Japan approved for use in the SFA. Its approval also makes Zilver PTX the only drug-eluting peripheral stent available in that country.

“The Zilver PTX peripheral stent represents progress in treating PAD,” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division. “Drug elution has come to the periphery for a reason. Clinical trials show that Zilver PTX has better long-term patency outcomes than bare-metal stents.”

Mitsuo Asami, vice president of Cook Japan and leader of Cook Japan’s Peripheral Intervention division added, “We are proud that this approval will bring Zilver PTX to Japanese physicians and patients. We intend to continue to support all medical practitioners by providing safe and minimally invasive treatment options for PAD.”

In a cooperative, multinational regulatory effort, a clinical trial for this product was carried out by Cook in Japan, the United States and Germany, with data from the trials being used to support regulatory submissions for Zilver PTX in Japan, the United States and Europe.  The Zilver PTX Drug-Eluting Peripheral Stent offers physicians treating PAD in the SFA the combination of mechanical support via stenting with the drug paclitaxel to reduce the risk of restenosis. It is under U.S. Food and Drug Administration review and is not available for sale in the U.S. It received CE mark approval in August 2009. The device is now available in more than 45 countries.

For more information: www.cookmedical.com

Related Content

Resolute Onyx Drug-Eluting Stent Noninferior to Polymer-Free Drug-Coated Stent With One-Month DAPT
News | Stents Drug Eluting | September 30, 2019
The first randomized trial to compare a durable polymer drug- eluting stent to a polymer-free drug-coated stent in...
Biodegradable Polymer Stent Plus Shortened DAPT Safe and Effective in Unprotected Left Main CAD
News | Stents Drug Eluting | September 30, 2019
A biodegradable polymer everolimus-eluting stent (BP-EES) followed by four months of dual antiplatelet therapy (DAPT)...
Superiority of Orsiro Over Xience Demonstrated in STEMI Patients
News | Stents Drug Eluting | September 05, 2019
Biotronik's ultrathin Orsiro stent demonstrated superiority over Xience with respect to target lesion failure (TLF) at...
Resolute Onyx Stent With Improved Radiographic Visibility Found to Be Safe and Effective
News | Stents Drug Eluting | October 01, 2018
October 1, 2018 — Recent results from the BIONYX randomized clinical study showed the novel, thin-strutted, polymer-c
Boston Scientific Receives FDA Approval for Eluvia Drug-Eluting Vascular Stent
Technology | Stents Drug Eluting | October 01, 2018
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA)...
Eluvia Drug-Eluting Stent Demonstrates Superior Patency in IMPERIAL Trial
News | Stents Drug Eluting | September 26, 2018
Positive 12-month data from the late-breaking IMPERIAL trial was presented at the 2018 Transcatheter Cardiovascular...
Titanium-Nitride-Oxide Stent Superior to Bioabsorbable DES in Acute Coronary Syndrome Patients

Image courtesy of Hexacath

News | Stents Drug Eluting | May 31, 2018
Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-...
Orsiro DES Shows Lowest Two-Year Target Lesion Failure in BIO-RESORT Trial
News | Stents Drug Eluting | May 31, 2018
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials...
OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES
News | Stents Drug Eluting | May 29, 2018
Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early...
Overlay Init