Medtronic, Boston Scientific, St. Jude Medical escape catheter patent suit

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gavelA trio of medical device companies yesterday escaped a patent infringement lawsuit filed by the inventor of a catheter after a federal judge in Wisconsin ruled that the case was filed in the wrong jurisdiction.

Imran Niazi in April sued Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT) subsidiary St. Jude Medical in the U.S. District Court for Western Wisconsin, alleging infringement of U.S patent 6,638,268 covering a coronary sinus catheter.

The companies moved to dismiss the case, arguing that it lacked jurisdiction in light of the U.S. Supreme Court decision in TC Heartland v. Kraft Foods Group Brands, which limited the ability of patent holders to sue in other states.

Yesterday Judge James Peterson found for the defendants based on the Heartland ruling, according to court documents.

“In these cases, it is undisputed that none of the defendants are incorporated in Wisconsin, so none of them ‘reside’ here. As to the second option for establishing proper venue, some of the defendants admit that they sell accused products in this district and some deny that they do, but all of the defendants deny that they have ‘a regular and established place of business’ in the district, so the court will focus on that issue,” Peterson wrote. “In light of the absence of any evidence or even allegations from Niazi that any of the defendants have a regular and established place of business in this district, the court concludes that Niazi has failed to show that venue is proper here.”

Peterson also ruled against allowing Niazi to proceed with discovery to prove residence in the western Wisconsin district, according to the documents.

“In these cases, Niazi has not identified any basis for believing that discovery will show that any of the defendants have a place of business in this district. Even if the court assumes as Niazi suggests that some of the sales people might keep some inventory at their homes, that type of de minimis evidence would not be sufficient to show that a defendant engaged in business from the employees’ homes,” he wrote. “To avoid questions about jurisdiction after a transfer, the court will dismiss the cases so that Niazi and the assignee can refile after determining the proper parties.”

Japan clears Abbott’s Mitraclip

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Abbott's Mitraclip

Abbott (NYSE:ABT) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its MitraClip transcatheter mitral valve repair device, cleared for indications of treating people with mitral regurgitation.

Currently, standard of care treatment for mitral regurgitation in Japan is limited to open-heart surgery and medication, Abbott said. Clearance of the catheter-based MitraClip system adds a minimally-invasive treatment option not previously available in the region, the company added.

The MitraClip is designed to be delivered to the heart through a blood vessel in the leg, securing portions of the leaflets of the mitral valve with a clip to allow the heart to pump blood more efficiently through the body.

“It is our mission to help people suffering from structural heart disease return to better health and quality-of-life by providing technologies and therapies that advance how people are treated. With the approval of our revolutionary MitraClip device in Japan, we can help more people live better by reducing the severity of their extremely life-altering illness in a safe and predictable way,” structural heart biz VP Michael Dale said in a press release.

Approval in Japan came based on data from the AVJ-514 clinical trial in the region, which reported an 86.7% rate of 2+ or less mitral regurgitation and classified 96.7% of patients as NYHA class I or II with no major adverse events at 30 days.

“MitraClip provides a new treatment option for many people with severe mitral regurgitation who cannot undergo the mitral valve surgery. The introduction of MitraClip therapy in Japan will help more people who previously had limited options return to better health faster, with dramatically reduced symptoms,” trial principal investigator Dr. Kentaro Hayashida of Tokyo’s Keio University said in a press release.

Last week, Abbott said it won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there.

Price caps to keep Abbott’s Xience Sierra off the Indian market

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  • TCT 2017: Abbott’s Xience coronary stent helps patients feel better faster than open-heart surgery

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    Abbott logoAbbott (NYSE:ABT) reported today that patients who were treated with the company’s Xience coronary stent for left-main coronary artery disease felt better faster compared to patients who had open-heart surgery.

    The data were presented at this year’s Transcatheter Cardiovascular Therapeutics meeting during a late-breaking session.

    “For any treatment, it’s important to not only consider clinical outcomes such as recurrent heart attacks or stroke, but also to consider the effect of the treatment on a patient’s quality of life,” study investigator Dr. Suzanne Baron said in prepared remarks.

    Get the full story at our sister site, Drug Delivery Business News.

    Abbott wins FDA nod for Confirm Rx smartphone-connected cardiac monitor

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    Abbott logo

    Abbott (NYSE:ABT) said today it won FDA clearance for its Confirm Rx insertable cardiac monitor, touting it as the 1st and only smartphone compatible ICM designed to help identify cardiac arrhythmias.

    The Confirm Rx system includes a sensor designed to be implanted just under the skin over the chest in a minimally-invasive outpatient procedure, the company said.

    The newly cleared device features incorporated Bluetooth wireless technology to allow patients to connect to the device on their smartphone devices through Abbott’s myMerlin mobile application. Data collected by the device is also transmitted to the patient’s physician on a schedule set by the practitioner, the company said.

    “Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care. By offering a device that uses Bluetooth wireless technology from the patient’s smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device,” cardiac rhythm management biz medical director Dr. Avi Fischer said in a press release.

    The company’s associated myMerlin app allos patients to track symptoms and sync data with their clinics at any time as well as viewing transmission history to confirm data transfer without havin to contact their clinci. All transfers are encrypted using the “highest standards in mobile security,” Abbott said.

    Last week, Abbott saw share prices tick up in pre-market trading after the healthcare giant posted sales and profits that beat the consensus forecast on Wall Street.

    Abbott’s $5B acquisition of Alere set to close tomorrow

    Abbott to acquire Alere

    Abbott (NYSE:ABT) said today it is looking to close its $5 billion acquisition of Alere (NYSE:ALR) tomorrow, saying it has received all regulatory clearances necessary.

    The Abbott Park, Ill.-based company said the acquisition will establish it as a “global leader in point of care testing,” which it sees as the fastest growing segment of the $50 billion in vitro diagnostics market.

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    The post Abbott’s $5B acquisition of Alere set to close tomorrow appeared first on MassDevice.

    UPDATE: Abbott plans to close $5B Alere buyout next week

    Abbott to acquire AlereUPDATED Sept. 29, 2017, with U.S. Justice Dept. news.

    Abbott (NYSE:ABT) said today that it plans to close its once star-crossed merger with Alere (NYSE:ALR) next week, after U.S. and Canadian anti-trust regulators yesterday approved the deal subject to concessions.

    Abbott agreed to divest a blood gas testing system to Siemens (NYSE:SI), which also agreed to buy two Alere facilities in Ottawa. Quidel (NSDQ:QDEL) Corp. is slated to buy Abbott’s heart function testing system business and an Alere facility in San Diego.

    Abbott offered to acquire Alere in February 2016. After several snafus, the company finally agreed to purchase Alere for $5.3 billion – down from its initial $5.8 billion price tag. The deal is now slated to close Oct. 3, Abbott said.

    “Creating the world’s leading point of care business will help Abbott meet the growing demand for fast, accurate and actionable information,” diagnostic products EVP Brian Blaser said in prepared remarks. “Combined with Abbott’s existing point-of-care business and its leading hand-held platform, i-Stat, we now have the broadest point of care testing portfolio to help improve care for patients in more parts of the world.”

    Abbott said the Alere buyout should take its diagnostics revenues to about $7 billion annually.

    Alere yesterday agreed to pay more than $13 million to settle SEC charges that it committed accounting fraud; today the Waltham, Mass.-based company said the U.S. Justice Dept. closed its probe into Alere’s dealings with third-party distributors and foreign healthcare officials without taking any action against Alere.

    “We are pleased that this matter has been closed with no action taken against Alere,” the company said.

    The post UPDATE: Abbott plans to close $5B Alere buyout next week appeared first on MassDevice.

    Abbott nabs U.K. reimbursement win for FreeStyle Libre CGM

    Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitoring system will be available for reimbursement in the U.K., starting on Nov. 1.

    The company’s system is designed to automatically read glucose levels through a sensor that’s worn on the back of a person’s upper arm for up to 14 days, thereby eliminating routine finger sticks.

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