Med Device Online reports that Medtronic has been cleared by the Federal Trade Commission (“FTC”) and EU’s European Commission to merge with Covidien.  Also according to Med Device Online, the companies had to agree that Covidien would sell Stellarex, its drug-coated balloon stent business division, to Spectranetics for $30M USD in order to obtain FTC and European Commission approval for the merger.

The FTC originally issued an administrative complaint against the merger. The FTC noted in its complaint that C.R. Bard, Inc. is currently the only supplier of drug-coated balloon catheters indicated for the femoropopliteal artery.  In addition, Medtronic and Covidien are the only two companies seeking FDA approval for drug-coated balloon catheters indicated for the femoropopliteal artery (both companies are now in clinical trials).  Therefore, in its complaint the FTC held that without the sale of Stellarex, Medtronic’s acquisition of Covidien would likely create an unfair and anti-competitive advantage for the companies in that market space.  On Nov. 26, 2014, following the companies’ agreement to sell Stellarex, the FTC cleared the merger on unanimous approval.

The European Commission noted that Stellarex, which recently obtained promising results from its first clinical trials, competes directly with Medtronic’s leading drug-coated balloon device, the “In.Pact.”  Therefore, despite (or perhaps due to) there being few active competitors in that market, the European Commission found it likely that Covidien would have competitively constrained Medtronic and that the acquisition would remove a credible future competitor from an already-dense market, thereby reducing innovation in the field of drug-coated balloon catheters.  Following the FTC’s lead, the European Commission gave its approval of the merger on Nov. 28, 2014.

According to Medtronic, the deal is scheduled to close in early 2015.

According to its website, Medtronic is headquartered in Minneapolis, Minnesota, and operates in more than 140 countries. Medtronic is the world’s 3rd largest medical device company, developing and manufacturing devices and therapies to treat more than 30 chronic diseases, including: heart failure, Parkinson’s disease, urinary incontinence, Down’s syndrome, obesity, chronic pain, spinal disorders, and diabetes.

According to its website, Covidien is headquartered in Dublin, Ireland, and also operates globally.  The company, which was spun off from Tyco International in 2007, develops and manufactures medical devices and supplies, for varied applications, including: vascular therapy, airway and inhalation therapy, oximetry and medical monitoring, soft tissue repair, and general surgery.