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Cordis receives regulatory approvals for additional sizes of Sleek OTW platform

Cordis has received European CE marking and U.S. Food and Drug Administration (FDA) approval for additional sizes of its SLEEK OTW platform, a 0.014 inch ultra-low profile percutaneous transluminal angioplasty (PTA) dilatation catheter.

The Cordis SLEEK OTW PTA Dilatation Catheter is a balloon catheter meant to treat patients undergoing peripheral angioplasty procedures below the knee.

First launched in 2011, Cordis will commence commercializing the new sizes immediately in various countries around the world.

For many patients suffering with end-stage peripheral arterial disease (PAD), lower limb amputation is the last resort.

According to estimates about 160,000 lower limbs are amputated every year in the US and 60-70% of these amputations are performed as the first-line therapy.

These lower-limb amputations come with a mortality rate of about 70% at five years.

The SLEEK OTW catheter offers a balance of pushability with a small crossing profile, which helps doctors to restore blood flow to the lower limbs of the patients.

Cordis now offers additional lengths of 20mm and 280mm for many of its current diameters.

The new 280mm length will allow physicians to treat diffuse disease with fewer inflations. The SLEEK OTW catheter is claimed to be the only peripheral balloon coming with an ultra low profile of 1.25mm diameter option.

The addition of new sizes will mean that the Cordis SLEEK OTW platform will offers doctors the broadest 0.014 over-the-wire catheter portfolio.