FDA Approves Medtronic's Guardian Sensor 3, Resolute Onyx 2.0 mm DES

Medtronic had both its Guardian Sensor 3 CGM system and it's Resolute Onyx 2.0 mm drug-eluting stent approved by the FDA.

The US Food and Drug Administration (FDA) has granted a new indication to the Guardian Sensor 3 continuous glucose monitoring system, now enabling patients to wear the Medtronic device on their upper arm.

The Guardian Sensor 3 system is meant to be utilized in combination with the MiniMed 670G hybrid closed-loop system, which is approved for use in patients with type 1 diabetes. The system features Medtronic’s SmartGuard algorithm, which automatically adjusts basal insulin delivery every few minutes to increase the patient’s time in range.

"The performance of the Guardian Sensor 3 has been extremely impressive, and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs," Bruce Bode, MD, FACE, a specialist with Atlanta Diabetes Associates and a clinical associate professor at Emory University, said in a statement. "These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimizing outcomes through technological advancements—that can prove to be just as meaningful for [the] quality of life."

Also today, Medtronic announced the FDA’s approval and US launch of the Resolute Onyx 2.0 mm Drug-Eluting Stent (DES), the tiniest stent available designed for small vessels, according to the company. It is intended for the treatment of patients with coronary artery disease (CAD) who have vessels small enough to be untreatable with larger stents during percutaneous coronary intervention (PCI).

"Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures," Matthew J. Price, MD, an interventional cardiologist at the Scripps Clinic in La Jolla, California, and the national principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, which the FDA considered in its approval, said in a statement. "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 stent was built with the lowest crossing profile of any DES, according to Medtronic, with a size of less than 1 mm. Once delivered, it is designed to expand from 2.0 mm to a diameter of 3.25 mm, the maximum labeled expansion.

It is estimated that 65% of smaller vessels—less than 2.25 mm—are in locations in the heart that are considered critical. In the RESOLUTE ONYX trial, which included 101 subjects (104 lesions) the rate of target lesion failure (TLF) at 12 months was 5.0%, meeting the target goal of 19% (P <.001).

Additionally, the rates of revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. The rate of binary restenosis was 12.0%, and in-stent late lumen loss was 0.26 ±0.48 mm.

"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 2 approvals bring Medtronic to 4 approvals this year, giving it a hot start in 2018, after receiving FDA approval for 12 devices in 2017.

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