Medtronic has had a busy first half of 2022 as it has built its leadership team, strengthened its portfolio through acquisitions and made strides in its spine technology.
1. Medtronic will acquire Affera, a company that focuses on cardiac mapping and navigation. Affera's technologies include the Affera Prism-1 cardiac mapping and navigation platform and the Sphere-9 cardiac ablation catheter. The deal is expected to close in the first half of Medtronic's fiscal year 2023.
2. Medtronic on Jan. 6 issued a Class I recall of the company's Synergy Cranial and StealthStation S7 Cranial software. The FDA identified this as a Class I recall, indicating the product could cause serious injury or death. The recall was issued because of potential inaccuracies with the Biopsy Depth Gauge Cycle View. Four complaints have been filed regarding the issue; there have been no reported injuries or deaths.
3. Medtronic's Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator were approved by the FDA for treating chronic pain associated with diabetic peripheral neuropathy. Independent studies have shown spinal cord stimulation led to an average 53 percent decrease in pain reduction compared with conventional treatments.
4. Mike Marinaro was named as operating unit president for surgical robotics. Mr. Marinaro has been with Medtronic for more than 20 years, where he previously led the cardiac rhythm management operating unit. Under his tenure, Medtronic launched and scaled the Micra leadless pacemaker product line, which generates more than $400 million in revenue annually.
5. Medtronic promoted Laura Mauri, MD, to serve as chief scientific, medical, and regulatory officer. Dr. Mauri joined Medtronic in 2018 and became part of the devicemaker's executive committee in 2020. Her new responsibilities include leading the integration of medical expertise into Medtronic's business process.
6. Medtronic completed its $1.1 billion acquisition of Intersect ENT. The acquisition grows Medtronic's ENT portfolio with the Propel and Sinuva product lines.
7. Medtronic saw record sales for its spine robots in the fourth quarter of fiscal year 2022 even as the market is loaded with competition. The record sales were reported despite a largely unchanged revenue in Medtronic's entire neuroscience segment in the fourth quarter.
8. Medtronic hired Ashwini Sharan, MD, as chief medical officer of the company's neuromodulation operating unit. Dr. Sharan will help shape the direction of innovation and clinical evidence plans and work with the medical community to address its needs.
9. Medtronic received FDA 510(k) clearance and breakthrough device designation for its LigaPass 2.0 ligament augmentation system. LigaPass was developed by Medicrea, which Medtronic acquired in late 2020. It is the only device the FDA has cleared for ligament augmentation in spine surgery.
10. Medtronic named Lidia Fonseca as an independent director of its board of directors. Ms. Fonseca, executive vice president and chief digital and technology officer at Pfizer, will serve on Medtronic's compensation committee and science and technology committee.