Benzinga | Jan 10, 2022 09:51AM EST

Medtronic's Evolut Pro TAVR Approved In China, Acquires Cardiac Arrhythmia Treatment Developer Affera

Medtronic Plc's (NYSE:MDT) CoreValve Evolut Pro TAVR system has received National Medical Products Administration approval in China.

* The approval marks the first Medtronic TAVR system approved in China for patients with symptomatic severe aortic stenosis at high or extreme risk for open-heart surgery.

* Medtronic's approval of the self-expanding TAVR system is based on clinical data from more than 32,000 patients, which showed high survival, low stroke rates, minimal paravalvular leak, and excellent hemodynamics. The company plans to do a full commercial launch in early 2022.

* Separately, Medtronic agreed to acquire Affera that designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies.

* Medtronic has been a strategic investor through its minority investment portfolio. It currently owns a 3% ownership stake in Affera.

* Medtronic did not disclose the value of the acquisition. The company expects the transaction to close in 1H of FY23.

* Following the close of the acquisition, Medtronic expects it to be less than 1% dilutive to its adjusted EPS in each of the first three years, then neutral-to-accretive after that.

* Price Action: MDT shares are down 0.90% at $104.22 during the market session on the last check Monday.