Boston Scientific seeks to block J&J unit’s Hotwire in new heart-device patent case

The story

Boston Scientific has opened a second patent front against Atraverse Medical, the heart-device company acquired by Johnson & Johnson earlier this year. A complaint filed in the U.S. District Court for the District of Delaware alleges that Atraverse’s Hotwire radiofrequency guidewire infringes U.S. Patent No. 12,733,955, titled “Methods and Devices for Puncturing Tissue.” The case was filed on October 7 and made public the following day. Atraverse was served on October 8 and, according to the public docket, its response is due October 29.

The dispute concerns transseptal access, a technique used to reach the left side of the heart by crossing the wall between the atria. Hotwire delivers radiofrequency energy through a distal electrode to create an opening in the atrial septum. That access can be part of procedures for conditions including atrial fibrillation. The U.S. Food and Drug Administration classified the product as a septostomy catheter and found it substantially equivalent through the 510(k) pathway in May 2024.

Boston Scientific’s patent was issued on September 15, 2026, to inventors Gareth Davies, John Paul Urbanski, Ferryl Alley and Bogdan Beca. The complaint says the claimed technology uses electrical energy to assist tissue puncture and is designed to reduce device exchanges during a transseptal procedure. Those descriptions are allegations and patent-language summaries from the plaintiff; they are not findings that Hotwire uses every element of a valid claim.

The company alleges direct infringement of at least claims 1 and 22 through making, using, importing, offering and selling Hotwire. It also alleges induced infringement, arguing that Atraverse instructs physicians to use the device in the accused manner. Boston Scientific says it notified Atraverse’s counsel of the newly issued patent on September 17 and claims continued sales are willful. Atraverse and J&J had not publicly answered the allegations when Reuters reported the case.

Boston Scientific is asking for preliminary and permanent injunctions, damages no lower than a reasonable royalty, lost profits, enhanced damages for alleged willfulness and attorneys’ fees. The complaint does not state a dollar amount. None of those remedies has been awarded, and the patent has not been adjudicated valid or infringed in this case. The presumption of validity that accompanies an issued U.S. patent does not prevent an accused company from challenging it in court.

The new action builds on litigation Boston Scientific filed against Atraverse in August 2025 over Hotwire. That earlier case now includes several patents in the same family. The new ’955 patent is described in the complaint as a later continuation descended from the earlier rights. Continuation practice allows an applicant to pursue additional claims based on an existing disclosure while earlier family members proceed, provided statutory requirements are met.

That procedural structure matters commercially. A product may be designed and launched while related patent applications remain pending. As new claims issue, a patent owner can evaluate whether they create additional infringement theories. The accused company can respond by arguing non-infringement, invalidity or other defenses. A newly issued family member therefore changes the litigation map, but it does not automatically establish that the marketed device falls within its claims.

FDA clearance and patent rights answer different questions. The 510(k) process assessed whether Hotwire was substantially equivalent to a legally marketed device for regulatory purposes. It did not grant Atraverse freedom to operate under third-party patents, and it did not evaluate Boston Scientific’s infringement allegations. Conversely, obtaining a patent does not constitute regulatory authorization to market a medical device or proof that the invention delivers better clinical outcomes.

INNOVOX analysis: the central issue will be claim-by-claim evidence, not the broad similarity that both companies work on electrically assisted transseptal access. Boston Scientific attached a claim chart mapping Hotwire to claims 1 and 22, but Atraverse has not yet presented its response. The case also illustrates the strategic value—and uncertainty—of a live continuation family: it can protect successive formulations of an invention, while forcing competitors to monitor claims that may issue after commercialization.

What to watch next is whether Boston Scientific presses for an early injunction that could affect Hotwire sales before trial, and whether the court coordinates the new case with the 2025 action. Atraverse’s answer should identify its non-infringement and validity defenses. Later claim-construction rulings will define disputed patent terms, while technical discovery will test how the guidewire delivers energy and crosses tissue. Until then, this remains a contested allegation around a cleared and commercialized device, not a decision that J&J’s unit infringed.

INNOVOX analysis

The dispute is not simply about who first commercialized an RF guidewire. It will turn on whether Hotwire satisfies the precise limitations of the asserted claims and whether those claims survive validity challenges. Boston Scientific’s use of a newly issued continuation patent also shows how an active patent family can keep changing the legal boundary around an already marketed product.

What to watch

Watch Atraverse’s response, due October 29 according to the docket, and any request for preliminary relief. The key technical questions will emerge through claim construction, Atraverse’s invalidity defenses and comparison of Hotwire with claims 1 and 22. The related 2025 case may also affect scheduling, discovery and possible consolidation.