Abbott wins Japanese reimbursement nod for MitraClip

Abbott (NYSE:ABT) said today that it logged a reimbursement win in Japan for its MitraClip device for treating mitral valve regurgitation.

The Chicago-area medtech giant said Japan’s Ministry of Health, Labor & Welfare granted national reimbursement for MitraClip, effective April 1. The MHLW approved the device last November for treating severe degenerative mitral regurgitation functional mitral regurgitation.

“Our mission is to develop technologies and therapies that help people return to better health and quality-of-life as quickly as possible,” structural heart VP Michael Dale said in prepared remarks. “With this reimbursement in Japan, we can help more people live better by reducing the severity of an extremely life-altering illness in a safe and predictable way.”

MitraClip won pre-market approval from the FDA in October 2013.

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Judge rips into Abbott’s diabetes test strip supplier over discovery fraud

A supplier that sells an international version of  Abbott‘s (NYSE:ABT) FreeStyle Diabetes test strips committed discovery fraud when it forked over only a select group of relevant documents last year, according to a U.S. magistrate judge. Lois Bloom ruled that the supplier, H&H, lost the right to invoke attorney-client privilege when it is deposed about the document production.

The spat dates back to October of 2015, when Abbott requested documents from an array of international pharmacies, distributors, importers and suppliers of its test strips. In January last year, a judge held a conference between Abbott and the named organizations to address various discovery issues.

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

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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Abbott wins FDA nod for pediatric Masters Series mechanical heart valve

Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world.

The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release.

The newly approved 15mm version of the device clears the valve for use in pediatric patients who previously had no options, the FDA said.

The agency claims that more than 35,000 babies are born in the US each year with congenital heart defects, many of which will require replacement heart valves that, prior to the approval, were not available.

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said in a press release.

Approval came based off clinical data from a single-arm study of 20 pediatric patients, between the ages of 1.5 weeks and 27 months, with serious heart failure in which the device was used as a mitral valve replacement.

Data from the study showed that one year post-implant, survival rates were 69.3% while the rate of freedom from valve-related adverse events was 66.8%, according to the FDA release.

Serious adverse valve-related events noted during the study include blood clots in the device and brain bleeds. The FDA said that anticoagulation therapy may be required to help prevent device clotting.

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Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues


Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio.

Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report.

A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports.

A total of 33 patients were followed for up to 38 months in the Leadless trial, with a single patient unable to receive the Nanostim device due to a problem.

Survival at three years was reported at 74%, with no deaths reported as being related to the device, according to the report.

The rate of freedom from serious adverse events was reported at 89.9% at 40 months, with three patients experiencing device-related complications, according to Healio.

One patient had a reported procedure-related perforation leading to cardiac tamponade, another had an inadvertent placement of the device through a patent foramen oval leading to removal and re-implantation, while the last had a battery malfunction at 37 months that caused loss of communication, with the device being removed and replaced, according to the report.

No incidents of late device dislodgements, device infections or pacemaker syndrome were reported, and at three years electrical performance of the device was reported as being adequate, Healio reports.

“The overall [leadless cardiac pacemaker] complication rate of 10.1% is comparable to previous reports of transvenous pacemaker complications. Development of a new battery should resolve [the battery malfunction] issue. The adequate performance and freedom from [serious adverse device effects] at midterm follow-up in this first-in-humans patient cohort support the use of leadless pacing as an alternative to transvenous pacing, especially considering the promise of decreasing long-term pacemaker complications,” study author Dr. Fleur Tjong of Amsterdam’s AMC Heart Center said, according to the report.

Abbott’s FreeStyle Libre glucose monitoring app launches in Europe


Abbott (NYSE:ABT) said today that it launched an app for its FreeStyle Libre glucose monitoring system in Europe that can be used with both iPhone and Android smartphones.

The mobile app is designed to give people with diabetes direct access to their glucose data on their smartphones. Without the app, FreeStyle Libre users have to carry a separate, handheld device to scan the system’s sensor for a glucose reading.

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

Ex-baseball pro DeCinces testifies in insider trading trial


Advanced Medical Optics, AbbottFormer professional baseball player Doug DeCinces reportedly testified this week in the second trial of friend and neighbor James Mazzo, the former Advanced Medical Optics CEO accused of insider trading ahead of Abbott‘s (NYSE:ABT) $2.8 billion AMO acquisition in 2009.

Federal prosecutors in 2014 accused Mazzo of tipping former Orioles and Angels player DeCinces about the upcoming merger (Abbott sold the business to Johnson & Johnson (NYSE:JNJ) for $4.33 billion last year). DeCinces allegedly passed that information on to former teammate Eddie Murray, who later agreed to settle his case for $358,000 but admitted no wrongdoing; DeCinces agreed in 2011 to pony up $2.5 million (but admitted no guilt) to settle similar charges leveled by the SEC and was found guilty of insider trading in May 2017.

Judge Andrew Guilford of the Central California court initially declared a mistrial in Mazzo’s case after a jury deadlocked on the charges against him. But that jury also convicted DeCinces and a business associate on charges of tender offer fraud, despite deadlocking on other charges against DeCinces and all of the charges against Mazzo.

Mazzo, now global ophthalmology president at Carl Zeiss Meditec (ETR:AFX) after a 3-year run as president and CEO at AcuFocus, had argued that there is “no evidence” of him “lying, cheating, or hiding anything.”

After failing to win a bid for dismissal of the second case brought against him last year, Mazzo went to trial again in the California Central court.

In yesterday’s testimony DeCinces confirmed that he bought AMO on Jan. 5, 2009, a day after meeting Mazzo for dinner, according to the LA Times.

After the meal, DeCinces said Mazzo asked if he was comfortable with how much AMO stock he owned.

“Very comfortable,” DeCinces said he replied. “‘This is a once-in-a-lifetime opportunity,’” Mazzo responded, according to DeCinces.

“As we were leaving, [Mazzo] mouthed the words, ‘Buy more,’” DeCinces said, according to the newspaper. “Based on what I heard the night before, I felt like I did not have enough stock.”

Mazzo’s attorney, Richard Marmaro, then questioned DeCinces’ credibility based on his own trial last year.

“When your lawyer said that Mr. Mazzo never provided insider information, was that the truth?” Marmaro asked DeCinces.

“No,” DeCinces answered.

“Was your attorney not acting without your authorization?” the defense lawyer asked.

“I cannot control what my attorney says,” DeCinces replied, adding that he was “very worried” after making the trades, the paper reported.

“I felt I made a huge mistake,” he said. “At that point, there was nothing I could do to take it back.”

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


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


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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