News | June 12, 2017

Resolute Onyx 2.0 mm Stent Performs Well in Small Vessels

First-Ever Study on 2.0 mm DES, EuroPCR Late-Breaking Data Show Exceptional Deliverability and No Stent Thrombosis for the Resolute Onyx DES
 

Onyx DES 2.0 mm stent meets primary endpoints in small vessels

June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failure (TLF) at one year for the treatment of coronary artery disease in extra-small vessels. Results from the RESOLUTE ONYX 2.0 mm Clinical Study were presented today as a late-breaking trial session at the 2017 EuroPCR annual meeting and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.

 
It is estimated that approximately 65 percent of extra-small vessels are located in critical locations of the heart, making them significant lesions to treat.[i] Designed specifically for extra-small vessels, Resolute Onyx 2 mm DES yielded excellent clinical outcomes in the study compared to a pre-specified performance goal with patients experiencing significantly low rates of TLF at one year (5 percent, p≤0.001). The study enrolled 101 patients with extra-small vessel sizes (2 – 2.25 mm) who received the Resolute Onyx 2 mm diameter DES across 20 sites in the United States and Japan.
 
“Treating coronary disease in extremely small arteries presents a real clinical challenge, as these lesions tend to be located in difficult-to-reach areas of the heart, have greater restenosis rates, and until now, we lacked the right stents to treat them safely and successfully,” said Matthew J. Price, M.D., interventional cardiologist at Scripps Clinic in La Jolla, Calif. and principal investigator of the RESOLUTE ONYX 2 mm Clinical Study who presented the one-year data at EuroPCR. “The excellent clinical performance we observed demonstrates the importance of designing stents like the Resolute Onyx DES that address a relevant unmet need. Thinner struts with enhanced radiopacity and a lower crossing profile provide excellent deliverability, and the stent can be over-expanded to treat tapered, challenging lesions.”
 
In the study, the events included in the TLF primary endpoint were low at one-year, as defined by low target-vessel MI (3 percent), low target lesion revascularization (2 percent) and no cardiac death. Additionally, Resolute Onyx DES showed no stent thrombosis.
 
The Resolute Onyx DES 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. This enables greater deliverability and conformability to the vessel wall. With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core Wire Technology also enables thinner struts while maintaining structural strength.
 
The Resolute Onyx 2.0 mm diameter DES are for investigational use only in the United States. The Resolute Onyx DES received approval by the Food and Drug Administration (FDA) in April 2017 and is now available for use in the United States for a broad range of sizes from 2.25 – 5 mm. It is also approved for use 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.

Read the article “FDA Approves Medtronic Resolute Onyx Drug-eluting Stent.”

For more information: www.medtronic.com

Reference:
1. Schunkert et al. JACC July 1999

Related Content

CorInnova Awarded 2017 InnoSTARS Prize for EpicHeart Soft Robotic Heart Assist Device
News | Artificial Heart| December 11, 2017
CorInnova Inc. recently announced it was awarded second prize in the “2017 InnoSTARS” life science competition for its...
Edwards Acquires Harpoon Medical
News | Heart Valve Technology| December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Robocath Receives $1.5 Million in Capital for Advancement of R-One Robotic System
News | Robotic Systems| December 06, 2017
December 6, 2017 — French company Robocath, which designs and develops...
New data on the Corvia intra-atrial shunt to treat diastolic heart failure were presented at the recent 2017 American Heart Association (AHA) Scientific Sessions. It was the most popular story in November.

New data on the Corvia intra-atrial shunt to treat diastolic heart failure were presented at the recent 2017 American Heart Association (AHA) Scientific Sessions. It was the most popular story in November.

Feature | December 06, 2017 | Dave Fornell
Here is the list of the most popular articles and videos on the Diagnostic and Interventional Cardiology (DAIC) magaz
New Tool Predicts Risk of Heart Attack in Older Surgery Patients
News | Cardiac Diagnostics| December 05, 2017
A tool designed to more accurately predict the risk of heart attack in older patients undergoing non-cardiac surgery...
Toshiba Medical Rolls Out Interactive Learning Tools for Ultrasound and Vascular Training
News | Ultrasound Imaging| December 04, 2017
Toshiba Medical, a Canon Group company, introduced new educational tools and interactive learning resources to help...
Philips Azurion Platform Improves Clinical Workflow and Staff Experience Benefits
News | Angiography| December 04, 2017
Philips recently announced the results of a comprehensive, independent, two-year study demonstrating the clinical...
Studies find 15 percent of all heart attack and stroke patients and 9 percent of CABG patients were uninsured before passage of the Affordable Care Act. AHA 2017, #aha2017
News | November 25, 2017
November 25, 2017 — The majority of patients without health insurance who were hospitalized for heart attack, stroke
The Corvia intra-atrial shunt to treat diastolic heart failure.

The Corvia intra-atrial shunt to treat diastolic heart failure.

Feature | Heart Failure| November 25, 2017
November 25, 2017 – Results presented at the 2017 American Heart Association (AHA) Scientific Sessions and published
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init