Cook’s Zilver® PTX™Peripheral Stent Gains Australian Approval

“If I’m treating patients with claudication with moderate to long lesions in the SFA, who have sub-optimal results after angioplasty, my first-line treatment is the drug-eluting stent”

In short

Last October we covered US FDA’s panel review of Cook medical’s Zilver® PTX™ Drug Eluting Stent for use in peripheral vascular applications, here. In that article the device, which was CE marked in 2009, received a unanimous recommendation from the FDA committee and is expected to gain FDA approval in the near future. Then earlier this month we announced that the product had gained first-of-its-kind approval for use in Japan.

Now Cook Medical has announced that the product has gained regulatory approval in Australia.

Background

Zilver PTX is a self-expanding stent made of nitinol, a ‘shape memory’ metal that offers unique mechanical advantages for an SFA stent. The stent is coated with the drug paclitaxel, which is delivered to the cells in the vessel wall to reduce the risk of restenosis. Zilver PTX comes in a 6 Fr delivery system and in stent lengths of up to 120 mm.

The product is designed specifically for stenting in the Superficial Femoral Artery (SFA) of patients suffering Peripheral Artery Disease (PAD). This combination therapy device, can reportedly reduce SFA restenosis rate by 50% and has gained approval from Australian regulator, TGA, so is now available to physicians across Australia as a completely new treatment option.

Supporting study

The proven drug effect of Zilver PTX was determined in the largest ever randomised, prospective SFA trial to date. The study findings demonstrated how the drug-eluting stent (DES) sustains a high primary patency rate through 24 months.

The trial involved 479 patients; the 241 in the Zilver PTX cohort had 83.1% primary patency after 12 months. When evaluated at 24 months, the patency rate was 74.8%. As the trial data indicates, the results achieved in the first year have been largely maintained throughout 24 months, an important clinical milestone.

Clinician comments

Associate Professor Andrew Holden, Director of Interventional Radiology at Auckland City Hospital, New Zealand, and consultant to Cook Medical, has been treating lesions in the SFA with the Zilver PTX drug-eluting stent for almost two years in his New Zealand practice. He states; “There are significant challenges to stenting in the SFA, the most important being long term durability and freedom from in-stent restenosis. The Zilver PTX clinical trial data has demonstrated 2 year patencies, superior to most bare metal stent trials. My own experience is consistent with this – significantly reduced restenosis rates with the Zilver PTX. If I’m treating patients with claudication with moderate to long lesions in the SFA, who have sub-optimal results after angioplasty, my first-line treatment is the drug-eluting stent”

Company comments

“Cook Medical is bringing drug elution to the periphery; Zilver PTX has been clinically proven to be significantly more effective in treating peripheral arterial disease in the SFA than traditional balloon angioplasty (POBA) and bare metal stenting (BMS),” said Rob Lyles, vice president and global leader of Cook Medical’s Peripheral Intervention division.

Source: Cook Medical