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Long-Length Drug-Eluting Stent from Medtronic Gets FDA OK
Resolute Integrity Stent Sizes of 34mm and 38mm Uniquely Indicated for Patients with Diabetes
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Medtronic's Resolute Integrity Drug-Eluting Stent |
February 25, 2013 -- Medtronic Inc. (NYSE: MDT) announced this morning that its Resolute Integrity zotarolimus-eluting stent was approved by the FDA in two additional longer lengths, 34mm and 38mm.
As the only drug-eluting stent (DES) currently approved by the FDA specifically for use in diabetic patients, the availability of stent lengths that can be used in long lesions, which are more common in diabetics, solidifies the positioning of the Resolute Integrity as a primary choice for the treatment of coronary artery disease in these patients.
Advantages of Treating Long Lesions with a Single Stent
The ability to use a single stent for the treatment of long lesions has advantages in patient safety, clinical outcomes and cost-effectiveness. Lacking an extra-length stent, long lesions, typically found in the more diffuse disease seen in diabetics, must be treated with two or more shorter overlapping stents. It is at this overlap that in-stent restenosis is more likely to occur. Likewise, if the proximal or distal areas of the diseased artery are not completely covered by the stent struts, the likelihood of disease progression, called edge restenosis, also is higher.
In these cases, the patient may need to return to the cath lab for a repeat revascularization. Reinforcing the FDA's approval was data from the RESOLUTE US and RESOLUTE Asia studies. In these studies, diabetic patients treated with these longer-length stents had a target lesion revascularization rate of only 2.4% at one year.
Dr. Ronald Caputo |
One of the difficulties historically seen for successful implantation of long-length stents was pointed out to Angioplasty.Org by Dr. Ronald Caputo, director of cardiac services and cardiology research at St. Joseph's Hospital in Syracuse, NY:
"Older stent designs, first generation stent designs, I don't think would be capable really of providing the opportunity to implant one long stent like this. Clinically the fewer times that you have to go in and out of an artery, the better. Shortening procedure time, hopefully decreasing fluoroscopy times, all those things will probably be very beneficial in the long run. The great deliverability of the Resolute stent makes placement of a long single stent possible."
Use of Resolute Integrity Drug-Eluting Stent Gaining
The Resolute Integrity drug-eluting stent has been gaining wide acceptance since its initial FDA approval a year ago. The device has already increased Medtronic's DES market share in the U.S. by 20 points; in the company's quarterly fiscal report last week, DES revenue was up 42%. Although Boston Scientific, one of Medtronic's chief competitors in the U.S. market, gained FDA approval for a longer length DES last summer, both Boston Scientific and Abbott Vascular, the third drug-eluting stent manufacturer in the U.S. market, have recently reported downturns in their DES sales.
This morning's press release from Medtronic, Inc. follows:
FDA Approves Longer Lengths of Medtronic's Resolute Integrity Stent
New Sizes of Implantable Medical Device Target Long Coronary Lesions Common Among Diabetes Patients
February 25, 2013 -- Minneapolis -- Expanding the applicability of its marquee product for the interventional treatment of coronary artery disease in the United States, Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm with an indication for patients with diabetes.
Now available to cardiac catheterization laboratories nationwide, these new sizes of the Resolute Integrity stent enable the treatment of long coronary lesions, which are generally considered to span more than 27mm.
Like the core sizes approved by the FDA in February 2012, the 34mm and 38mm lengths of the Resolute Integrity stent are uniquely indicated for treating the coronary artery disease of patients with diabetes, who commonly present with long lesions.
"Long coronary lesions and diabetes represent two distinct but often interrelated clinical challenges," said Ronald Caputo, M.D., director of cardiac services and cardiology research at St. Joseph's Hospital in Syracuse, N.Y. "The new sizes of the Resolute Integrity drug-eluting stent address both challenges in a single device. They have the potential to reduce procedure time and cost for clinicians and hospitals, as well as vessel trauma and contrast exposure for patients."
FDA approval of the 34mm and 38mm lengths of the Resolute Integrity stent is based on data from the global RESOLUTE clinical program –– specifically, a pre-specified analysis of one-year outcomes in patients with long coronary lesions who participated in the RESOLUTE US and RESOLUTE Asia studies.
The analysis included data on 222 patients who received a 38mm Resolute stent for the treatment of coronary lesions of no greater than 35mm in length. The primary endpoint for the analysis was target lesion failure (TLF) –– a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR) –– at one year of follow-up.
The long-lesion analysis met its primary endpoint, with a one-year TLF rate of 4.5 percent. Among the 38 percent of patients with diabetes, the one-year TLF rate was similarly low at 6.0 percent. The one-year rates of clinically driven TLR for all patients and the subset of diabetes patients were 1.4 percent and 2.4 percent, respectively.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology –– alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Reported by Burt Cohen, February 25, 2013; revised with comments from Dr. Caputo
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