Medtronic Nabs FDA nod for Onyx Frontier, Resolute Onyx DESs to Treat Bifurcation Lesions

“The Onyx Frontier and Resolute Onyx DESs are the only products approved for bifurcation PCI in the US, with a specific indication for the treatment of non-left main bifurcation lesions using the Provisional technique,” wrote a Medtronic spokesperson in a statement to MD+DI. “Unique stent attributes found in the Onyx Frontier and Resolute Onyx DESs are important to help optimize each procedural step”.

The Resolute Onyx DES is a Zotarolimus-Eluting Coronary Stent System consisting of a “balloon-expandable, intracoronary, DES premounted on a Rapid Exchange or an over-the-wire stent delivery system,” according to the “instructions for use” manual. “[It’s] manufactured from a composite material of cobalt alloy and platinum-iridium alloy and is formed from a single wire bent into a continuous sinusoid pattern and then laser fused back onto itself. The stents are available in multiple lengths and diameters. The delivery system has two radiopaque markers to aid in the placement of the stent during fluoroscopy and is compatible with 0.014-inch (0.36-mm) guidewires and 1.42- mm (5-Fr/0.056-in) minimum inner diameter guide catheters.” The stent offers flexibility, conformability, a 2-to-5-millimeter size matrix and is indicated for high bleeding risk patients.

The Onyx Frontier DES features the same stent design differentiators that provide conformability, visibility, fast healing, and size matrix while including enhancements like a dual-flex balloon, a lower crossing profile, and increased catheter flexibility.

“… Since patients with bifurcation lesions often present unique challenges for interventional cardiologists, stent attributes – like those found in the Onyx Frontier and Resolute Onyx drug-eluting products – become important to optimize the treatment of these lesions,” Medtronic wrote, in a press release announcing the FDA approval. In the statement sent to MD+DI, a Medtronic spokesperson expanded on the process of placing the stent in these patients:

“The process of placing a stent in a bifurcation using the provisional technique starts with initial placement of a stent in the main branch of the vessel.  After placing the stent, it is recommended to use the post-optimization technique to post-dilate the stent and ensure optimal strut apposition. Once the main branch is stented, the interventional cardiologist will use a guidewire to re-access the side branch.  Side branch access is a common concern in Bifurcation PCI, and the rounded struts found on the Onyx Frontier and Resolute Onyx DESs can help facilitate easier side branch access. After wiring the side branch, a balloon dilatation catheter is delivered and inflated to open the stent cell. If results are optimal, the procedure is complete. If the physician determines the side branch needs additional treatment, a second stent may be used to optimize results.”

Of note, Medtronic highlighted it is the only company offering DESs featuring a single wire design – a manufacturing process in which a single strand of wire is formed into a sinusoidal wave to construct a stent – optimizing treatment of complex bifurcation anatomy. Both the Onyx Frontier and Resolute Onyx DESs are FDA and CE mark approved.

“Prior to this, no company could support training on bifurcation stenting technique in the US,” according the statement from a Medtronic spokesperson. “Physicians will now have access to best-in-class products and training to better optimize the treatment of their CAD patients who have bifurcation lesions.”

Original Article: (https://www.mddionline.com/regulatory-quality/medtronic-nabs-fda-nod-onyx-frontier-resolute-onyx-dess-treat-bifurcation-lesions)