Final defendant sentenced in insider trading case

Federal prosecutors have wrapped up an insider trading case based on alleged tips from a Bank of America consultant on pending corporate transactions, including Abbott‘s (NYSE:ABT) $25 billion acquisition of St. Jude Medical.

Rodolfo Sablon, 39, of Miami, Fla., was sentenced Friday to six months in prison for his role in the insider trading scheme based on tips from Bank of America technical consultant Daniel Rivas. U.S. District Judge Alison Nathan also sentenced Sablon to two years of supervised release, including six months in a community confinement center, and ordered him to pay $923,566 in forfeiture and a $5,000 fine. Sablon pleaded guilty in July 2018 to conspiracy to commit securities fraud and fraud.

In August 2017, U.S. authorities accused seven individuals of reaping more than $5 million in illicit profits based on tips from Daniel Rivas. Prosecutors said that childhood friends Rivas and Roberto Rodriguez conspired to trade on confidential information and colluded with Sablon, Rodriguez’s friend and roommate, to create an investment fund using proceeds from the inside trades with an ownership stake going to Rivas.

Rodriguez pleaded guilty in September 2018 to conspiracy to commit securities fraud and fraud in connection with a tender offer and was sentenced to one year and one day in prison, according to federal prosecutors. Michael Siva pleaded guilty in October 2018 to one count of conspiracy to commit securities fraud and fraud and was sentenced to 18 months in prison. Jhonatan Zoquier pleaded guilty in August 2018 to conspiracy to commit securities fraud and was sentenced to three months in prison. Jeffrey Rogiers pleaded guilty in August 2018 to conspiracy to commit securities fraud and was sentenced to three months in prison. The scheme brought in some $2 million in illegal profits, according to prosecutors. In all, tips from Rivas led to about $5 million in illegal gains, they said.

“Today’s sentencing of Rodolfo Sablon closes the book on this multimillion-dollar, multi-pronged insider trading scheme,” U.S. Attorney Geoffrey Berman said in a prepared statement. “Sablon and his co-defendants acted as though the securities laws that are designed to keep our nation’s marketplace fair did not apply to them. However, as they all have learned, our office is committed to identifying and prosecuting these types of insider trading networks.”

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Medtronic touts stroke data for HeartWare LVAD

Medtronic logo updatedA retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.

The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.

The 465-patient Endurance Supplemental study compared 308 patients implanted with the HeartWare HVAD and 157 patients implanted with arch-rival Thoratec‘s HeartMate II device; the HVAD-treated cohort was also managed with a pre-specified blood pressure strategy to try to cut the stroke rates seen in earlier trials.

Endurance Supplemental’s primary endpoint was the rate of transient ischemic attack or stroke with 24-week residual deficit at 12 months. Secondary endpoints included a composite of freedom from death, disabling stroke and device replacement or urgent transplantation and a comparison of stroke or transient ischemic attack between the HVAD-treated cohorts in Endurance Supplemental and the original Endurance trial.

Although Endurance Supplemental missed the primary endpoint, with a 14.7% stroke rate for the HVAD cohort and 12.1% for the HeartMate II group, HVAD patients a 76.1% rate of freedom from the secondary endpoint’s adverse events compared with 66.9% for the control arm. Stroke rates were 24.2% lower for the HVAD cohort in the second trial compared with Endurance and hemorrhagic cerebrovascular accident was reduced by 50.5%.

Today Fridley, Minn.-based Medtronic said the two-year rate of freedom from disabling stroke for the HVAD group was 91%. Patients with the HeartWare device who had a stroke of any severity showed a lower rate of stroke-related mortality than patients implanted with HeartMate II, at 17% compared with 27%, respectively, the company said.

And there was a 23% reduction in total strokes, a 36% reduction in disabling strokes and a 39% reduction in stroke-related mortality in the HVAD arm of Endurance Supplemental, compared with the same arm in Endurance.

“This analysis shows that stroke severity is an important determinant of outcomes, and the use of the HVAD system with a guidelines-based blood pressure management strategy can, in addition to reducing overall stroke rates, reduce the occurrence of disabling stroke and improve survival in patients who experience strokes,” Dr. Jeffrey Teuteberg, of Stanford University, said in prepared remarks. “We also found that patients with a stroke in the HVAD cohort had better survival than those who received the control device. These results reinforce the importance of blood pressure management with the HVAD for end-stage heart failure patients.”

Medtronic said it’s also running a pair of real-world studies on the HVAD device, a 300-patient post-approval review of destination therapy patients called DT PAS and Apogee, which is designed to examine best practices in blood pressure management, anticoagulation/anti-platelet therapy and implant procedure in a DT PAS subset.

“Medtronic aims to advance the field of mechanical circulatory support and, consequently, the overall management of heart failure patients who can benefit from the therapy,” added cardiac rhythm & heart failure CMO Dr. Rob Kowal. “Continuing to define and drive best practices that reduce pump-related adverse events in a real-world setting is central to this patient-first strategy.”

Medtronic paid $1.1 billion in August 2016 for HeartWare, after cross-town rival St. Jude Medical paid $3 billion for Thoratec in October 2015; Abbott (NYSE:ABT) paid $25 billion for St. Jude in January 2017.

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Medical device cybersecurity: It’s time to get real

Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough?

[Original image courtesy of istockphoto.com]

[Original image courtesy of istockphoto.com]

Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration.

One group, the Healthcare & Public Sector Coordinating Council, thinks it has a solution: Health providers and other customers buying a connected medical device should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software. Available via remote access for customers, the CBOM would also include commercial hardware such as processers, network cards, sound cards, graphic cards and memory.

The council’s recently issued joint security plan calls for more vulnerability disclosures, notices of breaches, software and hardware upgrades and security patch availability. Companies would also need to notify customers before they end technical support for older devices.

“It’s this voluntary framework that establishes best practice for cybersecurity at a medical technology company,” council member Rob Suarez, director of product security at Becton Dickinson, told Medical Design & Outsourcing. “This joint security plan establishes the common ground which many medical device manufacturers, health IT vendors and healthcare providers agreed on.”

Some manufacturers have grumbled about providing hardware information in a CBOM, but an increasing number have pledged to publicly share vulnerability information should hackers breach one of their devices, including industry giants BD, Abbott, Siemens, Philips, Medtronic, Johnson & Johnson, Boston Scientific and Stryker.

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

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ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial

ACC 2019, Abbott

Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.

Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.

Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it frictionless and removing the need for mechanical bearings.

Study investigators recruited a total of 1,028 patients with severe heart failure for its MOMENTUM-3 trial at 69 U.S. centers. Patients in the trial either needed an LVAD as a bridge to a heart transplant or relied on the LVAD as a lifelong therapy, Edwards said.

Patients in the trial were randomized to receive either the HeartMate 3 or a HeartMate II system, and all received blood-thinning medications following surgery and were taking between 81 to 325 mg of Aspirin daily, the company said.

Data presented came from two pre-specified interim analysis and a final analysis at two-years post enrollment, Edwards said.

At two years, 74.7% of HeartMate 3 patients met the primary endpoint of the trial, compared with only 60.6% of patients with the HeartMate II. Pump replacement rates at two years was 2.3% for HeartMate 3 patients versus 11.3% for patients with a HeartMate II.

Rates of pump clotting were significantly lower for HeartMate 3 patients at 1.4% versus 13.9% for patients with HeartMate II devices. Rates of disabling stroke were closer between groups, at 5% for HeartMate 3 patients versus 7.5% for HeartMate II patients.

Rates of bleeding and gastrointestinal bleeding were reported at 43.7% and 24.5% respectively for HeartMate III patients, higher than the 55% and 30.9% reported for Heartmate II patients.

Patients treated with the HeartMate 3 spent on average 48 more days on LVAD support outside of a hospital than their Heartmate II counterparts and fewer days in the hospital after readmission, at 13 days versus 18 days, respectively.

Researchers noted an increased risk of infections at two years, and commented that they were working with infection disease experts to explore new ways to reduce infection susceptibility.

Study investigators said they plan to follow patients in the trial out to three years, and that they are looking to develop a new trial to explore how to optimize medical therapy for advanced heart failure patients.

“These final results from what is by far the largest LVAD trial ever conducted demonstrate the clinical superiority of the HeartMate 3 compared with its predecessor, the HeartMate II. We have shown a decrease in adverse events that uniquely occur due to the interface between the patient and the mechanical pump. These include a consistent and reliable reduction in strokes of all kinds and severity with the HeartMate 3 but also a remarkable reduction in the rate of pump-related blood clots and significant reductions in all types of bleeding, especially gastrointestinal bleeding. In addition to having significantly lower rates of adverse events, patients who received the HeartMate 3 had a lower rate of readmission to the hospital and spent fewer days in the hospital when they were readmitted,” lead author Dr. Mandeep Mehra of Brigham and Women’s Hospital said in a press release.

Mehra added that based on the results, he believes that the HeartMate 3 should be considered the standard of care for patients with advanced heart failure who do not respond to guideline-directed medical therapy.

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Abbott wins expanded indications for MitraClip

Abbott's Mitraclip

The FDA today said that it granted Abbott (NYSE:ABT) a new indication for its MitraClip system, expanding coverage of the device to patients with normal mitral valves with diminished left heart function.

The indication expands upon the original approval, which the Chicago-area medical device maker won in 2013, clearing it for use in reducing mitral regurgitation in patients with mitral valve abnormalities whose risks for mitral valve surgery were prohibitive.

With its new clearance, the MitraClip is cleared for use for patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation due to diminished left heart function despite treatment with optimal medical therapy.

The agency said that the approval will allow a small percentage of patients with chronic heart conditions and moderate-to-severe or severe secondary mitral regurgitation to be candidates for treatment with the MitraClip alongside optimal medical therapy.

The new approval came based on results from a 614-patient study of the device in patients with moderate-to-severe or severe secondary mitral regurgitation. Patients in the trial were treated with either optimized medication treatment and the MitraClip or medication only.

Results from the trial indicated a 47% reduction in rehospitalization for patients in the MitraClip group over the control arm, with a two-year risk of death drop of 37% for MitraClip patients.

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option. Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure,” FDA Center for Devices and Radiological Health Division of Cardiovascular Devices director Dr. Bram Zuckerman said in a press release.

Earlier this month, a review of FDA adverse event reports revealed that some Abbott implantable cardioverter defibrillator leads were much more likely to fail than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches.

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Study finds fault with ICD leads that Abbott inherited from St. Jude Medical

AbbottA review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR).

Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports of IBR breaches and other ICD failures. They found that insulation breaches led to 93% of Abbott’s (formerly St. Jude Medical’s) Durata pacemaker lead failures. All 11 failures to treat ventricular tachycardia/ventricular fibrillation were caused by high-voltage shorts between the proximal and distal right ventricular coil cables or sensing conductor. Testing showed low values of high-voltage impedance in three of the leads after a shock or an aborted shock or by an alert, they wrote in an article published in the journal Heart Rhythm.

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

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Abbott wins $35m Defense contract for TBI assay

AbbottAbbott (NYSE:ABT) landed a contract with the U.S. Defense Dept. to develop a diagnostic assay to detect traumatic brain injuries, the Pentagon said yesterday.

The Chicago-area healthcare giant was the lone bidder for the $35.2 million fixed-price contract, with an estimated completion date of Aug. 31, 2022.

The deal also comes with an immediate $12 million R&D, test and evaluation award for fiscal 2019, according to the Defense Dept.

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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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