Boston Scientific Files a Second Delaware Suit Against Atraverse, Asserting a Newly Issued Tissue Puncture Patent Against HOTWIRE.

The parties and the patent

The case is Boston Scientific Corp. v. Atraverse Medical, Inc., No. 1:26-cv-01294 (D. Del.). The complaint describes Boston Scientific Corporation as a Delaware corporation based in Marlborough, Massachusetts, and Boston Scientific Medical Device Limited as an Irish company based in Galway and a wholly owned subsidiary of Boston Scientific Corporation. It describes Atraverse as a Delaware corporation based in Cardiff-by-the-Sea, California. The '955 patent, titled Methods and Devices for Puncturing Tissue, issued September 15, 2026. Its face shows an application filed October 17, 2025 as a continuation of the application that issued as U.S. Patent 12,599,406, and it lists Atraverse's November 10, 2025 answer and counterclaims in the earlier Delaware case among the references cited. The complaint bases personal jurisdiction on Atraverse's Delaware incorporation and pleads venue under 28 U.S.C. 1400(b).

The asserted claims

The complaint asserts at least claims 1 and 22. Claim 1 covers a method of treating a condition on the left side of a patient's heart with a multi-function guidewire, which has a proximal section, a distal section, and a rail section between them, to reduce the number of exchanges a procedure requires. The guidewire is advanced into the vasculature with at least its proximal section inside a first tubular member. The distal section, when it is not inside that tubular member, is manipulated toward the right side of the heart, an end portion of the distal section is positioned substantially adjacent the septum, and an electrode at that end portion creates a puncture in the septum. The guidewire is advanced through the puncture into the left side of the heart, and the first tubular member is advanced over the guidewire into the left side.

Claim 22 covers a system built around the same kind of multi-function guidewire. The guidewire is configured to let a first sheath be advanced over it, to be advanced through the vasculature so that at least its distal section is positioned at the right side of the heart independently of that sheath, and to let an end portion of the distal section be positioned substantially adjacent the septum. It is electrically conductive, so that energy applied to it creates a puncture in the septum and the distal section can be advanced through the puncture into the left side of the heart, and it permits the first sheath to be advanced over it into the left side.

The accused product and the earlier case

The complaint accuses Atraverse's HOTWIRE device and quotes Atraverse's FDA 510(k) description of it as a "sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart." It alleges that Atraverse has sold HOTWIRE since receiving 510(k) clearance in May 2024 and relies on a claim chart attached as Exhibit B. It alleges, on information and belief, that Atraverse has directly infringed, literally or under the doctrine of equivalents, and has induced infringement by others, such as physicians using the device. The suit is brought under 35 U.S.C. 271.

The earlier case is Boston Scientific Corp. v. Atraverse Medical, Inc., No. 1:25-cv-01035 (D. Del.), filed August 18, 2025 on U.S. Patent 11,998,238. The new complaint calls the '238 patent the great-great-grandparent of the '955 patent and says the third amended complaint in that case asserts the '238 patent and U.S. Patents 12,433,639, 12,599,406, 12,636,040, and 12,653,576, all in the same family. In an amended disclosure statement filed there on May 20, 2026, Atraverse identified Biosense Webster, Inc. as its corporate parent.

Knowledge, willfulness, and relief

The complaint alleges, on information and belief, that Atraverse has known of the '955 patent since it issued. It points, among other things, to the earlier suit, an August 20, 2025 cease-and-desist letter, Atraverse's citation of U.S. Patent 10,368,911, to which the '955 patent claims priority, while prosecuting its own U.S. Patent 12,343,074, and a September 17, 2026 notice to Atraverse's counsel that the '955 patent had issued, with a copy of it. It pleads willful infringement, alleging that since at least September 15, 2026 Atraverse has been aware of an objectively high likelihood that its actions infringe. The prayer asks for a judgment of direct and indirect infringement, a preliminary and permanent injunction, a reasonable royalty and lost profits under 35 U.S.C. 284, a willfulness finding and enhanced damages, a determination that the case is exceptional under 35 U.S.C. 285, and attorneys' fees.

What to watch next

Watch for Atraverse's response, any motion to consolidate this case with No. 1:25-cv-01035 or to coordinate the two schedules, and whether Boston Scientific moves for the preliminary injunction its prayer requests. The case can end at any time by settlement or dismissal.