Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
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Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN), in a January 24, 2022 press release. The approval grants patients suffering from DPN access to both products within Medtronic’s spinal cord stimulation (SCS) portfolio. The IntellisTM neurostimulator is rechargeable whereas the VantaTM neurostimulator is recharge-free .
DPN, also referred to also as painful diabetic neuropathy (PDN), is a neurological disorder that impacts about 30% of individuals with diabetes, according to the press release. DPN occurs when high blood sugar levels damage nerves causing numbness, burning, or stabbing pain. Charlie Covert, a Medtronic vice president and general manager, views the new approvals as another example of Medtronic’s expertise:
DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life . . . This new indication enables us to apply Medtronic’s more than 40 years of proven SCS experience, as well as the company’s deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients
According to the press release, Medtronic estimates that the US market revenue for SCS treatment of chronic pain associated with DPN is approximately $70 million and expects market revenue to grow to $300 million by fiscal year 2026.
With the new approval, Medtronic’s IntellisTM and VantaTM neurostimulator products now join Nevro’s HFXTM for PDN as the only SCS devices with FDA approval for treatment of DPN/PDN. Nevro’s Chairman, CEO, and President, D. Keith Grossman, responded to the FDA’s approval of the IntellisTM and VantaTM neurostimulators in a press release, stating:
PDN represents a very large potential market, and having another competitor validate this large opportunity speaks to its attractiveness.
Nevro announced the FDA’s approval of its HFXTM on July 19, 2021.
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Albert Sueiras
Albert Sueiras is an associate in the Orange County office. Mr. Sueiras received his bachelor's degree in Biomedical Engineering, cum laude, from the University of Miami and also received his master's degree in Biomedical Engineering, cum laude, from the University of Florida. He received his J.D. from the University of Florida Levin College of Law, where he was a member of Phi Delta Phi.
During law school, Mr. Sueiras externed at the United States Patent and Trademark Office within Art Unit 3733, focusing on patent examination of orthopedic surgical instrumentation. Mr. Sueiras also participated in a patent prosecution externship at Banyan Biomarkers, Inc. in Alachua, Florida, a firm specializing in the discovery of biomarkers for traumatic brain injury and neurotoxicity.
Mr. Sueiras worked as a summer associate at the firm in 2015 and joined the firm in 2016.
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