Abbott touts real-world data for FreeStyle Libre glucose monitor

Abbott's FreeStyle LibreAbbott (NYSE:ABT) presented real-world data this week showing that use of its FreeStyle Libre glucose monitoring system reduced prolonged hypoglycemia and helped users achieve better glucose control.

At the 12th Advanced Technologies & Treatments for Diabetes meeting in Berlin, the company showcased a real-world evidence data set that included roughly 500,000 FreeStyle Libre system users.

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

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Abbott, Novo Nordisk ink deal for digital diabetes tools

Abbott, Novo Nordisk partnershipAbbott (NYSE:ABT) said today that it inked a non-exclusive deal to integrate insulin dose data from Novo Nordisk‘s (NYSE:NVO) pre-filled and connected pens with its FreeStyle Libre mobile app and cloud-based system.

The companies touted that integrating the products will allow healthcare professionals, caregivers and users to easily view glucose and insulin data, as well as make more informed treatment decisions.

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

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Here’s how a new Abbott device is making a difference among neonatal infants

Abbott Piccolo premie

[Image courtesy of Abbott]

A recent CBS News report provided a real-life example of how Abbott’s Piccolo occluder is making a difference among neonatal infants with a congenital heart defect called patent ductus arteriosus (PDA).

Irie and Judah Felkner are now healthy, growing 18-month-olds. But when Irie was born early at just 1 pound 13 ounces, she had a life-threatening PDA that left her mom Crissa Felkner scared that they weren’t going to bring her home.

“We saw that Irie’s heart was enlarging in size and more and more fluid was collecting in her lungs,” Dr. Aimee Armstrong, director of Cardiac Catheterization and Interventional Therapies at Nationwide Children’s Hospital, said in an Abbott news release.

Armstrong, who was Irie’s cardiologist, suggested her as a candidate for a clinical trial with the minimally invasive Piccolo device.

Dr. Evan Zahn of Cedars Sinai Smidt Heart Institute explained to CBS how the Piccolo device works: “The Piccolo device is advanced into the PDA just by gently pushing it out. That goes right into the PDA and plugs it almost immediately. We can reposition it by just drawing it back in the catheter and doing the whole thing over again until we think it’s perfect.”

Three days after the procedure, Irie Felkner was breathing on her own. She was one of the first babies treated with the device while Abbott was testing it out. FDA approved the device in January.

Abbott has more details about Felkner’s story on its website. 

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Thoratec inks $12m investor suit settlement deal

Abbott's Thoratec HeartMate II

Abbott (NYSE:ABT) owned Thoratec is seeking approval for a $11.9 million deal to settle class action claims that it and some of its officers hid facts about its Heartmate II heart pump’s thrombosis rate that would have negatively affected share prices, according to recently released court documents.

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 in October 2017 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 revived case included 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 last May.

In the new settlement deal, dated February 1, Thoratec agreed to pay $11.9 million to close out the cases, according to court documents.

Abbott acquired Thoratec when it bought St. Jude Medical in 2017. In May of that year, 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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Study: Procedures with Abbott’s Mitraclip show sustained low complication, mortality rates

Abbott's Mitraclip

Despite an increase in the number of procedures due to aging patients, minimally invasive mitral valve repair procedures using Abbott‘s (NYSE:ABT) Mitraclip system maintain a low mortality and complication rate, according to a new study from Mainz University Medical Center’s Center for Cardiology.

Researchers in the Germany-based study examined more than 13,575 minimally invasive mitral valve procedures, touting the study as the largest of its kind to date.

“Several studies with small groups of patients have already been published for the evaluation of the procedure with regard to the frequency of inserting the clip or the safety of the procedure. However, there have been no large data collections so far. That’s why it was a good idea to examine the implantation numbers and the complication rates in Germany on a larger scale,” study authors said in a press release.

Results from the trial indicated that despite annual implantation numbers increasing from 815 in 2011 to 4,432 in 2015, complication and mortality rates “did not change significantly during the period studied,” researchers wrote in a press release.

Investigators concluded that despite an approximately fivefold increase in implantation rates, “the procedure has very low early-stage complications rates during hospitalization.”

“Catheter-assisted valvular heart valve therapy has evolved from a niche treatment of inoperable patients into a relevant and safe treatment option in only ten years, as our new study emphasizes once again,” study author Ralph Stephan von Bardeleben said in a prepared statement.

Abbott acquired MitraClip in the $410 million acquisition of Evalve back in 2009. The device, which is designed to reshape the mitral valve to prevent blood from flowing backwards through the valve, won its first FDA nod in 2013.

Last September, startlingly positive results from a clinical trial of theMitraClip heart valve device reportedly drew applause at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego.

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Abbott again escapes payer’s lawsuit over St. Jude Medical CRM batteries

AbbottThe Medical Device Amendment’s pre-emption clause continues to provide legal cover for medtech companies in the U.S., with Abbott getting a payer’s lawsuit dismissed over the past week.

Abbott faced a purported class-action lawsuit that a third-party payer — the ASEA/AFSCME Local 52 Health Benefits Trust in Alaska — filed last year in federal court in Minnesota. The ASEA/AFSCME Local 52 Health Benefits Trust claimed that it and other third-party payers had to needlessly spend hundreds of millions of dollars because of the way that St. Jude Medical, now part of Abbott, handled a cardiac rhythm management device batteries recall.

U.S. District Judge David S. Doty, however, dismissed the case in an order dated Jan. 24.

Doty wrote that the lawsuit was similar to previously dismissed cases where judges found that the pre-emption clause of the Medical Device Amendment mostly bars lawsuits challenging the safety and effectiveness of medical devices with FDA pre-market approvals. Past cases including Medtronic Sprint Fidelis leads product liability litigation, Kinetic v. Medtronic, and Pinsonneault v. St. Jude Medical generally held that FDA should handle such safety and effectiveness claims, not the courts.

“Indeed, the allegations here are nearly identical to those raised in the above cases, particularly Kinetic,” Doty said in his order. “Thus, under Sprint Fidelis, Kinetic, and Pinsonneault, the court is constrained to conclude that plaintiff’s claims are preempted. As a result, the court must dismiss the case.”

“Because the claims are preempted, the court will not address whether the complaint is adequately pleaded,” Doty added.

Doty’s dismissal of the case comes about half a year after the U.S. District Court for Northern Illinois dismissed a similar lawsuit from the ASEA/AFSCME Local 52 Health Benefits Trust against Abbott, saying that it lacked jurisdiction. The health benefits trust then filed against Abbott in Minnesota, where St. Jude Medical is based.




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Abbott misses Wall Street expectations on Q4 sales

Abbott (NYSE:ABT) stock is down about 2% at the opening of trading today after its fourth-quarter sales failed to meet analyst expectations.

The Abbott Park, Ill.–based maker of medical device, pharmaceutical, nutrition and diagnostics products brought in about $7.765 billion in revenue in the quarter ended Dec. 31, 2018. The sales were up 2.3% from $7.589 billion earned during the same period a year ago but missed the $7.82 billion consensus of analysts polled on Yahoo! Finance.

Earnings actually met expectations, and Abbott’s board in December even upped the company’s quarterly dividend 14.3%, to 32 cents per share.

Fourth-quarter earnings were $654 million, or 37 cents per share, versus a loss of $828 million, or 48 cents per share, a year before. Excluding items, Abbott saw a profit of 81 cents per share, meeting Wall Street expectations.

For the full year of 2018, Abbott saw revenue of $30,578 billion, up 11.6% from $27.390 billion a year before. Earnings excluding items were $2.88 per share, up from $2.50 per share a year before.

Abbott CEO Miles D. White in a news release described 2018 as an outstanding year.  “We exceeded the organic sales growth range we set at the beginning of the year, achieved a number of significant advances in our pipeline, and significantly improved our balance sheet and strategic flexibility. We’re very well-positioned heading into 2019.”

Abbott’s medical device business performed especially well. Sales increased 6.7% year-over-year, to $2,920 billion, during the fourth quarter. For the full year, sales were up 10.1% on a reported basis and 9.1% on an organic basis.

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Abbott touts effective pain management, lower energy use in BurstDR SCS study results

Abbott (NYSE:ABT) late last week released results from a study of its BurstDR spinal cord stimulation technology, touting that it provided as effective pain relief as standard SCS despite providing lower-energy, intermittent stimulation known as “microdosing,” for patients with chronic intractable pain.

Results from the BOLD study were presented at the 22nd Annual North American Neuromodulation Society Meeting in Las Vegas, the Chicago-area medtech company said.

All patients in the BOLD trial reported experiencing pain relief with less than six hours of battery use per day while being treated with BurstDR, with 43% of patients reporting pain relief with less than two hours of battery use.

Abbott said that data from the trial may indicate a potential strategy for prolonging SCS battery life while still maintaining optimal pain relief, and could improve the viability of recharge-free SCS devices.

“While stimulation with BurstDR has been shown to provide superior efficacy compared to traditional stimulation in previous studies, battery consumption is an important consideration for physicians as we look to maximize the life of the devices for our patients and control their pain. This new data reinforces the benefits of BurstDR stimulation but also shows that microdosing BurstDR stimulation may help us extend device battery life for patients, which may help improve patient satisfaction with their SCS therapy,” primary investigator Dr. Timothy Deer of Charleston W.V.’s The Spine and Nerve Center of the Virginias said in a press release.

In a separate study, dubbed BURST(able), data indicated that patients who did not receive effective pain relief from their previous SCS therapy found restored pain control and reduced opioid dependency after switching to one of Abbott’s BurstDR waveform devices, the company said.

The BURST(able) trial was non-industry sponsored, and evaluated patients experiencing loss of pain relief from their non-Abbott SCS systems who switched to a BurstDR waveform device. Of the patients in the trial who were surgically implanted with the new device, 60% to 72% reported a reduction in pain and 41% to 52% a reduction in opiate consumption, the company said.

“As a pain specialist, one of the most difficult things to combat is patients developing a tolerance to their therapy and seeing SCS therapy lose efficacy over time. Loss of efficacy often leads to patients reverting back to chronic opioid therapy or left with no good alternative therapy options. I’m encouraged to see that, by switching to Abbott’s BurstDR stimulation, we can offer patients a neuromodulation treatment that is safe and effective while reducing reliance on opioid medication, regardless of their prior treatment,” primary investigator Dr. Corey Hunter of the Ainsworth Institute of Pain Management said in a prepared release.

“BurstDR stimulation has been used clinically now for many years and these latest data indicate that we’ve just scratched the surface of what’s possible. Our goal is to continue studying BurstDR stimulation to maximize its potential, even at extremely low doses, and allow people with chronic pain to live their best lives without the burden of recharging their devices and the fear of losing efficacy over time,” Abbott chronic pain therapies medical director Dr. Allen Burton said in a prepared statement.

Today, Abbott said that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation.

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FDA clears Abbott’s TactiCath Sensor Enabled AF contact force ablation cath

Abbott (NYSE:ABT) said today that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation.

The newly cleared TactiCath SE is intended to provide precise images of the heart overlaid with real-time electrical activity information, the Chicago-area medtech company said. The catheter also features an ergonomic design also used in the company’s FlexAbility catheter intended to improve reach and maneuverability.

“Cardiac ablation has become a front-line therapy in the fight against conditions like atrial fibrillation in part because of improvements to the technology available today. The Abbott TactiCath SE ablation catheter represents one of those major improvements, and offers an incredibly powerful, yet easy to use, combination of advanced technologies to improve ablation procedures,” Dr. Roger Winkle of Redwood City, Calif.’s Sequoia Hospital, who was one of the first to treat patients with the newly FDA-approved catheter, said in a prepared statement.

Abbott touted the addition to its electrophysiology portfolio, saying it has also recently launched its Advisor Sensor Enabled HD grid mapping catheter and FlexAbility Sensor Enabled ablation catheter.

“TactiCath SE directly supports our goal of supporting fast, effective and safe cardiac ablation procedures. As more physicians turn to cardiac ablation to treat AFib, Abbott’s goal is to equip them with the most advanced ablation catheters combined with the most advanced cardiac mapping on the market,” Abbott electrophysiology biz medical director Dr. Srijoy Mahapatra said in a press release.

Last week, Abbott said that it plans to acquire mitral heart valve replacement tech developer Cephea Valve Technologies for an undisclosed amount.

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Abbott inks deal to test blood donations in Japan

Abbott (NYSE:ABT) said today that it has been selected by the Japanese Red Cross Society (JRC) to partner in screening the country’s blood donations.

The eight-year contract is for the exclusive supply of serological instrumentation, tests, and consumables used for blood and plasma screening. The JRC screens approximately 5 million blood donations each year, helping ensure a safe supply of products needed for blood transfusions and plasma therapies. Abbott products are used to screen more than 60% of the world’s blood and plasma supply, according to a company statement.

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

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