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Medtronic's Resolute Onyx Stent Now Available in Diameters from 2.0-5.0mm
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Medtronic Resolute Onyx |
February 26, 2018 -- Based primarily on the results of the RESOLUTE ONYX 2.0 mm Clinical Study, first presented at the EuroPCR meeting in May 2017, the U.S. FDA has approved Medtronic's Resolute Onyx™ 2.0mm zotarolimus-eluting stent, making it the smallest diameter DES on the market.
The news, announced today by Medtronic plc (NYSE: MDT) means that the Resolute Onyx line is now available in the widest range of any coronary stent, from 2.0mm to 5.0mm, able to be placed successfully in the very narrowest arteries typically seen in diabetic patients or those post-CABG patients with narrow grafts, yet can also also be utilized in very large vessels, such as the left main stem.
Continuous Sinusoid Technology (CST) |
Unique Continuous Sinusoid Technology (CST)
The CST platform that Medtronic has adopted offers unique advantages in customizing stents to specific situations. Instead of laser-cutting the stent out of a cylinder, the Resolute Onyx line is made from a single strand of cobalt-chromium alloy, which is then formed into a sinusoidal wave. The inside of the strand can be constructed with a hollow core, allowing a variety of options. In the case of the 2.0mm Onyx, the core is filled with a radio-opaque platinum-iridium ribbon, making the very tiny device more visible under fluoroscopy during the procedure. In the case of future devices now under development, the core may consist of a drug which is delivered through tiny holes, eliminating the need for a polymer.
"Swaged" Construction
While the standard sizes of the Resolute stent have struts that are 91 microns thick, in order to reduce that strut thickness even further, the 2.0mm Onyx was constructed with "swaged" struts. As Dr. Matthew Price, principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, explained to Angioplasty.Org, the cobalt-chromium strand was "hammered" or flattened out to be more oval in shape, so that the thickness was only 81 microns while the strut width remained at 91 to retain its radial strength.
"The Ideal Catheter"
A unique property of the 2.0mm Onyx is the wide range of diameters it can treat. With a very tiny crossing profile of less than 1.0mm, the stent, once delivered to the blockage, can be dilated anywhere from 2.0mm to 3.25mm. This reminded us of the "wish list" of Andreas Gruentzig, the father of coronary angioplasty, who told us in an interview over three decades ago what would be "the ideal catheter." (Note that, at this time, stents had not yet been invented.)
Dr. Andreas Gruentzig |
"First of all it should be as small as possible. Second, the balloon should be as big as possible, being as small as it is.
Therefore, if I have a dilatation catheter which is as small as the guide wire, but has the capacity to inflate with the balloon, up to normal size of 2 or 3mm, that would be the ideal catheter, which has not been found yet, but we are coming closer to that point.
And then, of course, if you have that, you need on the other hand, catheters or instruments which could solve problems like getting rid of a dissection which is like a flap hanging in the lumen, obstructing the blood flow...."
Indeed, as Dr. Matthew Price, principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, told Angioplasty.Org, "We still have patients who have lesions and vessels that are less than 2.0, 2.25 in diameter. What to do with these patients is challenging. Do you do a stand-alone balloon angioplasty? Get a dissection, close the vessel. If you're outside the United States you use a drug eluting balloon, I guess. We don't have that in the U.S. There are still issues with dissection, and recoil."
In these patients, there is now a drug-eluting stent that will open the blockage and treat any dissection or recoil. Dr. Price's study, while relatively small at 101 patients, showed excellent results at one year. The primary endpoint, Target Lesion Failure, was a low 5% with no instances of stent thrombosis. Of note, almost half of the patients in the trial were diabetic.
This latest development in stent technology, along with many others, has made PCI safer and more effective, so much so that a major problem in conducting clinical trials today which compare devices or therapies is that the very low event rates mean a very large number of patients need to be included to see any differences at all.
This is actually good news for patients.
This morning's press release from Medtronic follows:
Medtronic Launches First 2.0 mm Drug-Eluting Stent in United States Designed to Treat Patients with Small Vessels
FDA Approved, Resolute Onyx 2.0 mm DES Technology Tackles Clinical Challenge of Treating Coronary Artery Disease in Previously Untreatable Patients
February 26, 2018 -- Dublin -- Designed specifically for small vessels, Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx™ 2.0 mm Drug-Eluting Stent (DES) - the smallest sized DES on the market. The new stent is intended to help interventional cardiologists treat patients with coronary artery disease (CAD) who have small vessels often untreatable with larger stent technologies during percutaneous coronary intervention (PCI). It is estimated that approximately 65 percent of smaller vessels (< 2.25 mm) are in critical locations of the heart, making them significant lesions to treat.[1]
Dr. Matthew J. Price |
"Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures," said Matthew J. Price, M.D., interventional cardiologist at Scripps Clinic in La Jolla, Calif., and national principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, which supported the recent FDA approval. "The Resolute Onyx 2.0 mm DES is an extremely deliverable stent that, when needed, can be post-dilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart."
The first-and-only 2.0 mm DES size available in the U.S., the newly approved stent joins the unique Resolute Onyx 4.5- and 5.0-mm DES to provide physicians with the broadest DES size matrix available, expanding treatment options for patients with the smallest coronary vessels to the largest, from the simplest of anatomies to the complex. In addition, the stent is engineered with the lowest crossing profile of any DES (less than 1 mm) enabling exceptional deliverability. Once delivered, the Resolute Onyx 2.0 mm DES is engineered to expand from 2.0 mm to the maximum labeled expansion diameter of 3.25 mm.
The Resolute Onyx DES platform is the first-and-only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. Core Wire Technology enables thinner struts while maintaining structural strength and visibility.
"Furthering our core objective of developing technologies that address unmet patient needs, the introduction of the Resolute Onyx 2.0 mm DES allows physicians to expand treatment options for patients with smaller vessels," said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. "The Resolute Onyx DES is an incredibly deliverable product that incorporates various design enhancements enabling physicians to optimize treatment for a wide range of patients."
The Resolute Onyx 2.0 mm DES is supported by the RESOLUTE ONYX 2.0 mm Clinical Study, which was presented at the 2017 EuroPCR Annual Meeting and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention. In the study, the Resolute Onyx DES met its pre-specified performance goal with low target lesion failure (5 percent), low target lesion revascularization (2 percent), no episodes of stent thrombosis and no cardiac death at 12 months.
The Resolute Onyx DES is available for use in all sizes in the United States, as well as in Europe and other countries that recognize the CE (Conformité Européene) Mark.
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 plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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.
[1] Schunkert et al. JACC July 1999
Reported by Burt Cohen, February 26, 2018
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