Medtronic makes FTC-mandated sale to close Intersect ENT deal and scores FDA nod to boot

It may have taken an order from the Federal Trade Commission to get there—and Medtronic may be getting less bang for its buck than initially expected—but the medtech giant’s acquisition of Intersect ENT is finally complete.

Just a few days after the FTC said the buyout could only proceed if Intersect ENT subsidiary Fiagon was sold off within 10 days of the deal’s close, Medtronic announced Friday that the entire deal has in fact crossed the finish line, sans Fiagon.

The freshly divested company makes the Cube ear, nose and throat navigation system and the VenSure balloon sinus dilation system. In an antitrust review of the planned acquisition, the FTC concluded that adding those technologies to Medtronic’s existing market-leading ENT portfolio would greatly reduce competition and innovation in an already very narrow space—therefore driving up healthcare costs for patients and providers.

The agency approved Intersect’s proposal to sell Fiagon to Hemostasis, which offered only one product in the ENT market before it acquired Fiagon’s assets. The terms of that sale weren’t disclosed.

Meanwhile, with Intersect now nestled snugly underneath the Medtronic umbrella, the FTC has forbidden the companies from purchasing any other ENT navigation or balloon sinus dilation tech without its express permission for the next decade.

The merger dates back to August 2021, when Medtronic offered $28.25 in cash for each of Intersect’s outstanding shares. That represented a 15% premium over the target’s stock price at the time and added up to a total of $1.1 billion.

The acquisition brings Intersect’s remaining ENT devices into the Medtronic family. They include a pair of bioabsorbable, steroid-eluting implants, both of which are indicated for patients with chronic rhinosinusitis, or CRS, and have been approved by the FDA. The Propel implant—which has also received CE mark clearance in Europe—keeps sinuses clear after an endoscopic sinus procedure, while the Sinuva device is inserted to treat nasal polyps that develop after ethmoid sinus surgery.

Under the terms of the deal, Medtronic took over Intersect’s facility in Menlo Park, California, as well as its entire staff.

“By combining Intersect ENT’s groundbreaking localized drug delivery products with the leading navigation and powered instruments of Medtronic, we can now equip physicians with the right tools for many unique patient needs,” said Vince Racano, president of the ENT business within Medtronic’s neuroscience segment. “This acquisition expands our portfolio, and we can now provide a more comprehensive continuum of care for CRS patients while supporting the bold ambition of Medtronic to be the global healthcare technology leader.”

Alongside the news that Medtronic can now begin selling Intersect’s steroid-delivering implants, the company also announced Friday that it has received FDA clearance for yet another of its drug-eluting devices.

The Onyx Frontier stent is placed inside a heart artery to prop open the blood vessel and treat plaque build-ups and blockages there that cause coronary artery disease. Compared to previous iterations of the Onyx stent, the newly cleared version offers a more flexible catheter and dual-layer balloon technology for more accurate and effective placement—which Medtronic said led to a 16% improvement in the stent’s deliverability compared to past versions.