Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
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.
Boston Scientific Files IPR Petitions Against Nevro
Boston Scientific filed two petitions with the Patent Trial and Appeal Board on May 14, 2015 requesting inter partes review of Nevro’s U.S. Patent No. 8,359,102. The petitions were assigned Case Nos. IPR2015-01203 and IPR2015-01204. The ‘102 Patent, which is entitled “Selective High Frequency Spinal Cord Modulation for Inhibiting Pain with Reduced Side Effects, and Associated Systems and Methods,” issued on January 22, 2013. Figure 1 of the ‘102 Patent is shown below.
The first petition seeks review of Claims 1, 2, 11-15, 17-23, 25, and 26 of the ‘102 Patent as obvious based on six different grounds: 1) Claims 1, 2, 11-14, 17-22, 25, and 26 were challenged as being anticipated by MacDonald (U.S. Pat. No. 5,776,170); 2) Claims 1, 2, 15, 17-18, and 25-26 were challenged as being anticipated by Sluijter (U.S. Pat. No. 6,246,912); 3) Claims 1, 2, 17-23, 25 and 26 were challenged as being anticipated by Royle (U.S. Pat. Pub. No. 2006/0009820); 4) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over MacDonald, either alone or in view of De Ridder (U.S. Pat. Pub. No. 2011/0184488), Sluijter, and/or Royle; 5) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Sluijter, either alone or in view of De Ridder, MacDonald and/or Royle; and 6) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Royle, either alone or in view of De Ridder, MacDonald and/or Sluijter.
The second petition seeks review of the same claims, though on only two different grounds: 1) Claims 1, 2, 17-22, 25, and 26 were challenged as being anticipated by Knudson (U.S. Pat. Pub. No. 2007/0073354); and 2) Claims 1, 2, 11-15, 17-23, 25, and 26 were challenged as being obvious over Knudson either alone or in view of De Ridder and/or MacDonald.
The petitions state that there is no related litigation.
Days before Boston Scientific filed the petitions, Nevro announced that its Senza spinal cord stimulation system received FDA approval. Nevro states that it “intends to vigorously defend its intellectual property in this matter.”
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