Abbott wins Aetna nod for Proclaim neurostim in chronic pain

Abbott (NYSE:ABT) said today that it won a reimbursement nod from Aetna (NYSE:AET) for its Proclaim dorsal root ganglion neurostimulation therapy for treating chronic pain.

The national coverage decision opens DRG treatment to some 22 million Aetna members, Abbott said. Aetna already covers treatment with Abbott’s spinal cord stimulation devices, the company said. It acquired the neurostim assets when it paid $25 billion for St. Jude Medical back in January 2017.

“Since its launch in the U.S., Abbott’s DRG stimulation has had a profound impact for people living with complex pain conditions. One of the most challenging stories we hear is when patients undergo a therapy trial, find pain relief and then learn their insurance won’t cover their therapy,” neuromodulation VP Keith Boettiger said in prepared remarks. “While Medicare already covers our DRG system, it’s encouraging to see private payers like Aetna review the clinical data and outcomes, then choose to provide access to DRG stimulation for their members. These decisions build on the momentum of broader national coverage decisions by private insurers and support the FDA’s goals to find new ways to combat the opioid epidemic with alternatives such as Abbott’s neurostimulation therapies.”

Last December CVS Health (NYSE:CVS) revealed its plans to buy Aetna (NYSE:AET) in a $69 billion merger that’s still pending.

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Abbott launches program to offset employee student loan debt

Abbott (NYSE:ABT) said today it is launching a program to aid its employees with paying off their student loans.

The new program, labeled the Freedom 2 Save program, will allow certain employees to receive matched deposits into savings program to match contributions meant to offset student loan debt.

“We see our young professionals coming to us with a problem: Student loan debt payments keep them from setting aside the money they’d like to put in savings for retirement. With every decade you wait to start saving for retirement, the amount you need to save roughly doubles. This plan will give participants savings equal to our company 401(k) match if they are putting at least 2% of their pay toward reducing their student loans. Helping them with this challenge is the right thing to do. Our employees have invested a lot in themselves to earn their way into Abbott, and we don’t want student loans to prevent them from beginning to save when time is on their side. With this program, we’re changing the retirement savings formula.” HR exec VP Steve Fussell said in a press release.

Abbott said that the program will be open to all employees who qualify for its 401(k) program and are contributing at least 2% of their eligible pay towards student loans.

Through the program, employees will receive an amount equivalent to its traditional 5% match deposited into 401(k)s, and will receive the match without having to contribute their own 401(k) contributions.

“I was out-of-state for my biomedical engineering degree, so my student loans are well more than the average. Paying it off is my number one goal. Abbott also has a tuition assistance program that I intend to use when I start graduate school in the fall, but the Freedom 2 Save program will be a huge help in making sure I’m saving for the future, while still aggressively paying off my loans,” Abbott engineer Rariety Monford, who said she plans to use the Freedom 2 Save program, said in a prepared statement.

Earlier this month, Abbott escaped a purported class action lawsuit brought by a third-party payer over defective batteries used in subsidiary St. Jude Medical‘s cardiac rhythm management devices.

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Abbott is developing a dual-chamber leadless pacer

Even before its acquisition by Abbott, St. Jude Medical had begun developing a dual-chamber leadless pacemaker, which would be a first if it succeeds.

Abbott and Medtronic are the only companies that have developed single-chamber leadless pacemakers; St. Jude recalled its version, Nanostim, in October 2017 after receiving 7 reports of lost telemetry and pacing output.

Get the rest of the story at our sister site, Medical Design & Outsourcing.

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FDA: Abbott’s Heartmate 3 recall is Class I

The FDA today labeled a recall of Abbott‘s (NYSE:ABT) Heartmate 3 left ventricular assist devices over possible twisting and eventual occlusion of the outflow graft as Class I.

A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death.

The HeartMate 3 devices are being recalled due to a malfunction in the outflow graft assembly which could cause the outflow graft to twist and occlude over time, which could result in a stalled pump flow and a persistent low flow alarm in the system, the FDA said.

The recall action is intended to update labeling and instructions for use for the device, Abbott clarified, and no units are being physically recalled.

A reduction in pumping can lead to serious adverse events, the agency warned, including blood clots and death.

The recall affects a total of 4,878 units in the US with catalog numbers 106524US, 106524 and 10652INT. The recall affects all lot numbers and all manufacturing dates for devices distributed between September 2, 2014 through to today, according to the FDA’s recall notice.

The FDA suggested that patients experiencing a persistent low flow alarm should contact the physician managing their HeartMate 3 system immediately. Abbott said that it is not recommending the devices be removed due to the issue.

Abbott began notifying patients of the issue as early as April, and provided updated guidelines for physicians implanting such devices and for patients currently implanted with the device.

The instructions included an additional LVAD surveillance echo exam at approximately two weeks after device implantation or before index hospitalization discharge and continued surveillance trans thoracic echo procedures at 1, 3, 6 and 12 months post-implantation.

Abbott initially released information on outflow graft twisting issues earlier this month after having received 32 reports of related issues.

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FDA approves Abbott’s latest drug-eluting stent

Abbott (NYSE:ABT) said today that it won FDA approval for its Xience Sierra everolimus-eluting coronary stent.

The company’s device features a thin profile, improved flexibility and longer lengths than previous stents. The device and delivery system were designed to help clinicians tackle complex cases, like those involving multiple or totally blocked vessels, according to Abbott.

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

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Stryker, J&J and Abbott ranked as top companies to work at in the U.S.

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Stryker, Johnson & Johnson and Abbott have been named as some of LinkedIn’s top companies to work at in 2018. This marks the third year of “LinkedIn’s Top Companies 2018: Where the U.S. wants to work now,” which names the companies that professionals most want to work at based on a set of data points collected from LinkedIn members.

LinkedIn annually ranks 50 companies based on actions taken by the 546 million professionals on the networking website. The metrics used are job demand, engagement with the company, interest in its employees and retention. LinkedIn then normalizes the results to measure companies against peers.

Get the full story on our sister site, Medical Design & Outsourcing.

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Investors win class certification in lawsuit against Abbott’s Thoratec

A group of Thoratec shareholders this week won a class certification in a revived suit claiming that Thoratec, now owned by Abbott (NYSE:ABT), and some of its officers hid facts about its HeartMate II heart pump’s rate of thrombosis that would have negatively affected share prices, thereby misleading investors.

Investor Bradley Cooper originally brought the suit against the company in January 2014, on behalf of anyone who bought stock between April 29, 2010, and Nov. 27, 2013. Plaintiffs in the case argued that the company failed to warn investors about a blood clot problem with its HeartMate II implant implicated in a Class I recall.

In 2013, the FDA said an improperly connected component in the implant may result in deformation or tearing of the device’s outflow conduit, putting the patient at risk of serious injury or death. A year before that, a study published in the New England Journal of Medicine showed a sharp increase in the rate of blood clots with the HeartMate II LVAD.

The Pleasanton, Calif.-based device maker issued a correction notice in February 2012, warning physicians that a small portion of the HeartMate II devices’ sealed outflow graft bend reliefs, designed to prevent a connector between the pump and the aorta from kinking, were not properly connected.

“Thoratec hid from its investors its own internal data confirming such reports and the related financial risk, and did not correct its prior disclosures. […] Thoratec did not disclose the extent of the impact that the reported increases had on HeartMate II’s commercial viability until August 6, 2014, causing its stock to drop some twenty-five percent,” according to court documents.

The suit was revived last October by a Ninth Circuit panel which decided it was a mistake that a lower court dismissed the case, and that investors had sufficient grounds for their claims that the company misled them.

The case now includes both Bradley Cooper and Todd Labak as plaintiffs, who both purchased shares in July and August 2013. Plaintiffs in the case were found to meet the appropriate rules for class certification, US District Judge Claudia Wilken ruled this week, according to court documents.

Abbott acquired Thoratec when it bought St. Jude Medical last year. Last May, Abbott recalled nearly 29,000 controllers for the HeartMate II implantable heart pump after 26 patients died trying to change out the controllers on their own.

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Speakers you need to see at DeviceTalks Minnesota

A Google executive whose own heart problems spurred her to seek medtech innovation, a leader at Abbott who wants to drive healthcare value, the head of an upstart company seeking to transform diabetes care — those are but some of the speakers you will encounter at DeviceTalks Minnesota this June.

Read on to find out more about some of the top speakers we’ve lined up for the show. And register soon to attend.


Attend DeviceTalks Minnesota, June 4–5 in St. Paul>>

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Abbott warns of outflow graft twisting issues with HeartMate 3

Abbott (NYSE:ABT) last Friday warned about possible issues with its HeartMate 3 left ventricular assist device over possible twisting of the outflow graft that can occur post-implant and could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting.

The Abbott Park, Ill.-based company is not recalling any such devices from patients or hospitals, but said it has received 32 reports of such twisting amongst the 4,467 HeartMate 3 devices implanted worldwide.

Reports include issues related to low blood flow, clotting and three deaths that could be linked to outflow graft twisting, Abbott said.

The company reported that it has begun contacting physicians and patients implanted with the HeartMate 3 in the event that they receive reports of persistent low flow alarms that could indicate such twisting.

Abbott said it has also notified the appropriate regulatory bodies of the issue, as well as implanting physicians to try and monitor and prevent future issues related to twisting, according to a press release.

Abbott won FDA approval for the HeartMate 3 implantable heart pump last August, cleared for patients awaiting a transplant.

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Abbott wins FDA nod for Advisor HD Gridcardiac mapping cath

Abbott (NYSE:ABT) said today it won FDA clearance for is Advisor HD Grid mapping sensor enabled catheter designed for creating highly detailed maps of the heart.

The newly cleared mapping catheter builds on the Abbott Park, Ill.-based company’s previous designs and and is intended to improve cardiac ablation procedures by providing an inside view of the heart for more accurate identification of the cardiac anatomy.

The Advisor HD Grid catheter is designed to capture data including the direction and speed of cardiac signals, and allows for the creation of high-density maps of cardiac tissue for more optimal treatment regimens, Abbott said.

The catheter’s sensor enabled technology can also improve accuracy of the cardiac image when paired with the company’s EnSite Precision cardiac mapping system, Abbott said.

“At the University of Chicago Medicine, we are passionate about understanding and redefining arrhythmia mechanisms with higher resolution cardiac mapping. Abbott’s Advisor HD Grid represents an important step in the development of next generation mapping catheters. With a flexible and soft design using magnetic sensor technology, the catheter helps capture signals previous catheters may have missed to support the creation of highly detailed 3D maps of the heart. Innovation within the field of electrophysiology continues to evolve toward improving our ability to visualize arrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result,” Dr. Roderick Tung if the University of Chicago Hospitals said in a prepared statement.

The Advisor HD Grid mapping catheter won CE Mark approval last December, the company said.

“The goal in developing the Advisor HD Grid mapping catheter, sensor enabled was to provide physicians with an innovative solution to quickly and accurately map complex arrhythmias in patients,” Abbott electrophysiology biz medical director Dr. Srijoy Mahapatra said in a press release.

Last month, a post-approval registry study of Abbott’s MitraClip mitral valve repair device showed positive results at one year, according to late-breaking results presented at the annual meeting of the Society for Cardiovascular Angiography & Interventions in San Diego.

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