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Medtronic reveals Endeavor Resolute DES nine month clinical trial results

Medtronic : 23 May, 2007  (New Product)
The nine month results from the Medtronic Resolute clinical trial show a low number of adverse cardiac events and no protocol-defined stent thrombosis.
Ian Meredith, MD, Monash Medical Centre, Melbourne, Australia, presented the results at the EuroPCR meeting in Barcelona, Spain.

The data showed a low number of adverse cardiac events and no protocol-defined Stent thrombosis.

The next-generation Medtronic Endeavor Resolute drug-eluting Stent system with new BioLinx polymer is designed to address the special needs of patients who have complex medical conditions and is engineered to match the duration of Drug delivery with the longer healing duration often required by these patients.

In clinical results at nine months, the Endeavor Resolute trial showed no Target Lesion Revascularisation (TLR), no Target Vessel Revascularisation (TVR) and a Major Adverse CardiacEvent (MACE) rate of just 7.0 percent.

Of the trial's 130 patients, 129 (99.2 percent) received clinical follow-up, and 95 had angiographic follow-up.

In-stent late lumen loss, the study's primary endpoint, was 0.22mm, while in-segment late loss was 0.12mm.

In-stent Angiographic Binary Restenosis (ABR) was 1.0 percent and in-segment ABR was 2.1.

'What is most impressive about these results is that they occurred in a patient population with complex and challenging characteristics', said Dr Meredith, the principal investigator of the trial, noting that the average lesion length in the Resolute trial was 15.5mm and nearly 82 percent of enrolled patients were classified as having challenging B2/C lesions.

'The Resolute trial enrolled a high percentage of patients with lesions that are difficult to treat, including small vessels and long lesions, and these results are extremely promising.

'Zotarolimus continues to be a very potent drug in preventing restenosis while the new BioLinx polymer appears to be delivering the drug as intended'.

Endeavor Resolute leverages the strengths of the Endeavor Stent and introduces BioLinx, a proprietary, biocompatible polymer designed by Medtronic scientists.

BioLinx is different from other polymers in that its outer surface is hydrophilic (water friendly), which leads to high biocompatibility with the body.

At the same time, the interior of the polymer is hydrophobic, which helps to control the drug release.

Some polymers can produce an inflammatory response within the blood vessel.
This can contribute to thrombosis or occlusion of the artery - outcomes that are more pronounced in patients with difficult lesions or complex medical conditions.

BioLinx is a non-inflammatory polymer blend that mimics the make-up of a cell membrane to maintain biocompatibility.

'The Medtronic drug-eluting Stent product pipeline is extremely strong, with clinical trial results that demonstrate an impressive combination of safety and effectiveness', said Scott Ward, president of the CardioVascular business at Medtronic.

'Endeavor Resolute is designed to complement Endeavor and provide physicians with a compelling choice of drug-eluting stents to match the specific needs of their patients.

'Medicine is very personal and these data clearly reinforce that we are achieving our mission of providing doctors with the products they need to provide the best possible care for their patients with coronary artery disease'.

The Endeavor Resolute Stent is not yet approved in any country.

Data from the Endeavor Resolute clinical trial will be used to support the CE Mark application.
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