Cook Medical wins FDA de novo nod for Hemospray

Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.

“We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States,” Cook Medical endoscopy VP Barry Slowey said in a prepared release.

“Hemospray gives clinicians another tool for the care of their patients. Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.,” Cook Medical MedSurg VP DJ Sirota said in prepared remarks.

The Hemospray powder is intended to absorb the water in blood to form a gel which acts both cohesively and adhesively to create a barrier to the bleeding site, Cook Medical said.

In its approval, the FDA said it reviewed data from studies of 228 patients with upper and lower GI bleeding alongside real-world evidence from medical literature reports which included data on an additional 522 patients. The Hemospray device was found to have stopped GI bleeding in 95% of patietns within 5 minutes of device usage.

The FDA said that 20% of patients experienced rebleeding between 72 hours and 30 days, and bowel perforations were observed in 1% of patients.

“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” FDA Center for Devices and Radiological Health surgical devices division director Dr. Binita Ashar said in a press release.

Early last month, Cook Medical said it re-launched its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.

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Judge: Firms must have permanent, physical presence in Delaware to file patent suits there

The District of Delaware Chief Judge said this week that businesses must have permanent residences in the state to be sued for patent infringement within it, following a series of US Supreme Court rulings, and transferred a patent spat case to Indiana.

Chief Judge Leonard Stark said the precedent was set after the Supreme Court’s decision in TC Heartland LLC v. Kraft Food Group Brands and Bristol-Myers Squibb Co. v. Superior Court of California earlier this year.

In TC Heartland v. Kraft Foods Group Brands, the Supremes limited the ability of patent holders to sue in other states. Kraft sued TC Heartland in its incorporated state of Delaware over drink powder patents; a lower court blocked TC Heartland’s bid to move the case to its home base of Indiana. In May, the Supreme court reversed that decision, finding that the only place a defendant can be subject to a suit is their home court, a place where infringement occurred or where the defendant has a regular and established place of business.

Similarly, in the Bristol-Myers SquibbCo ruling the pharmaceutical giant was sued by more than 600 plaintiffs alleging injuries from its Plavix drug. The justices overturned a California state court ruling that, although there was little connection between the lawsuits and the Golden State (only 86 plaintiffs hailed from the state), the lawsuits could proceed there because of the company’s extensive links there.

The opinion from Judge Stark comes from a patent spat case between Boston Scientific (NYSE:BSX) and Cook Medical, in which he granted a transfer of venue from Delaware to the Southern District of Indiana, Indianapolis Division.

“After reviewing thorough briefing and hearing oral argument, the Court finds that Defendants do not have a “regular and established place of business” in Delaware. Therefore, the Court concludes that venue is improper in Delaware for this action. Accordingly, the Court will grant Defendants’ motion and transfer this case to the United States District Court for the Southern District of Indiana, Indianapolis Division,” Judge Stark wrote, according to court documents.

Earlier this year, a number medical device makers were reportedly looking to slip patent infringement and product liability lawsuits based on the TC Heartlands U.S. Supreme Court ruling.

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