Medtronic plc MDT recently commenced the enrolment for a prospective, multicenter, global, post-market study of its InterStim Micro neurostimulator — Evaluation of InterStim Micro System Performance and Safety (“ELITE”) — for sacral neuromodulation (“SNM”) therapy. Notably, the neurostimulator was cleared by the FDA early this month and subsequently launched in the United States. It had received the CE Mark in January.
The study will enrol patients with overactive bladder (“OAB”), fecal incontinence (“FI”) and non-obstructive urinary retention across various sites in the United States (and its territories), Europe, Australia and Canada.
With the help of the ELITE study, Medtronic aims to fortify its position with respect to the SNM therapy, which is the gold standard in the industry. Notably, the InterStim Micro neurostimulator is a product of the company’s Pelvic health and gastric therapies — a business arm of the broader Restorative Therapies Group.
Significance of the Study Outcome
Approximately 37 million adults in the United States suffer from OAB, whereas nearly 18 million individuals have FI. Many such patients limit their social, professional and personal lives, while nearly 45% of the sufferers do not seek treatment.
Per the medical fraternity, although the SNM therapy has already been established as safe and effective, the ELITE study is expected to definitively reinforce the same in patients implanted with the new InterStim Micro system. This is expected to encourage more patients to seek the SNM therapy.
Notably, the SNM therapy was developed by Medtronic a long time back in partnership with physicians and is backed by the only existing five-year clinical data currently available in the market for all SNM indications.
Per a report by Reports and Data published on GlobeNewswire, the global SNM market was valued at $2189.1 million in 2018 and is projected to reach $3153.4 million by year 2026 at a CAGR of approximately 4.9%. Factors like rising elderly population, increasing incidents of neurological diseases and failure of conventional treatments are likely to drive the market.
Given the market potential, the study is expected to further establish the efficacy of the SNM therapy and boost Medtronic’s business.
Recent Developments in Restorative Therapies Group
Of late, Medtronic has been witnessing few developments in this business arm.
The company had received the FDA’s clearance for its InterStim SureScan MRI leads early this month along with the InterStim Micro neurostimulator.
In June, Medtronic received the FDA’s approval for its Percept PC Deep Brain Stimulation system.
Shares of the company have lost 7% in the past year compared with the industry’s 5.2% fall and against the S&P 500’s 16.1% growth.
Zacks Rank & Key Picks
Currently, Medtronic carries a Zacks Rank #3 (Hold).
QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).
Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.
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