Blog Tag: Intersect ENT

Medtronic Completes Acquisition of Cardiac Mapping Company Affera

Medtronic recently announced that its acquisition of Affera, Inc. has been completed. The acquisition was previously announced to be for $925 million with a $250 million contingency, as reported by MedCity News. Medtronic had previously been a strategic investor in Affera and, prior to the acquisition, owned a 3% interest in Affera as stated in a prior press release dated January 10, 2022.

Affera develops an integrated platform to deliver therapy to cardiac arrhythmia patients. The platform is referred to as Affera Prism-1™ cardiac mapping and navigation platform, per the announcement. Additionally, Affera also develops catheters, such as the pulmonary vein isolation pulsed field ablation catheter, as previously announced on July 27, 2021.

In the latest announcement, Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business, stated:

We’re incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment.

Founder and chief executive officer of Affera, Doron Harlev, also expressed excitement to be joining Medtronic by stating that “the acquisition enhances and accelerates our ability to treat millions of patients around the world suffering from cardiac arrhythmia with our innovative technology.”

This acquisition would be the second acquisition completed by Medtronic this year.  Earlier this year, Medtronic completed the acquisition of Intersect ENT, the developer of sinus implant technology, for $1.1 billion, as reported by MassDevice.

Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC

On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc.  The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell the assets of Fiagon NA Corp., a key subsidiary of Intersect ENT.  Medtronic sold Fiagon to Hemostasis LLC and was thereupon able to finalize the acquisition of Intersect ENT.

As a result of the transaction, Medtronic acquired Intersect ENT’s PROPEL™ and SINUVA™ (mometasone furoate) sinus implant product lines and technology, intellectual property, and Intersect ENT’s facility in Menlo Park, CA.  Intersect ENT employees joined Medtronic as a result of the acquisition.

SINUVA is an FDA-approved biosorbable, steroid-eluting implant that, according to Intersect ENT, is clinically proven to reduce polyps and symptoms of nasal congestion.  PROPEL is also an FDA-approved biosorbable, steroid-eluting implant, indicated for patients with chronic rhinosinusitis (CRS).  The PROPEL implant, which has reportedly also received CE mark clearance in Europe, is designed to keep sinuses clear after an endoscopic sinus procedure, while the SINUVA device is inserted to treat nasal polyps that develop after ethmoid sinus surgery.

Medtronic reports that acquiring Intersect ENT’s product lines and customer base will further Medtronic’s efforts to help patients who suffer from chronic rhinosinusitis, reported to be one of the most common health care problems in the U.S.

The FTC’s Bureau of Competition investigated the planned acquisition of Intersect ENT and determined that Medtronic, Inc., a wholly owned subsidiary of Medtronic plc, and Intersect ENT violated Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45.

An agreement was reached between Medtronic, Intersect ENT, and the FTC, pursuant to which Fiagon was sold to Hemostasis LLC.

Fiagon makes ear, nose, and throat navigation systems and balloon sinus dilation products.  According to the draft Complaint prepared by the FTC, without this divestiture, the acquisition of Intersect ENT by Medtronic would pose a threat to future competition in the United States for both ENT navigation systems and balloon sinus dilation products.

The press release by Medtronic is available here.