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Abbott warns of 2 potential safety issues with its heart implant

Abbott is warning of two separate potential safety issues involving its HeartMate 3 implant used to treat advanced heart failure, according to MedTech Dive.

The HeartMate 3 is designed as a long-term treatment for patients with advanced heart failure who can’t receive a heart transplant.

Medical professionals need to perform controller exchanges on the pumps every once in a while, but patients and caregivers are also trained to perform exchanges in case of an emergency.

Abbott warned that connecting the modular cable to the HeartMate 3 at the wrong angle when exchanging controllers can stop electrical power from reaching the pump, which can cause serious injury or death. The cable may seem like it is connected, but if it’s at the wrong angle, it won’t transmit electricity to the pump, according to MedTech Dive.

Abbott wrote in a Dec. 2 letter to clinicians that the problem has resulted in a reported death rate of 0.05 percent to date. It has also caused hemodynamic compromise — which is when blood flow from the device is reduced or stopped — in 0.07 percent of patients. The company did not specify the number of deaths caused by the problem.

The second issue is that excessive amounts of static electricity have caused unrecoverable power loss to the HeartMate mobile power unit modules. There have been two reports of serious injury connected to the issue, but no deaths. The serious injuries were hemodynamic compromise.

The static electricity problem only occurs when the HeartMate 3 system is used with the MPU Module, according to MedTech Dive. HeartMate II devices are not affected.

https://www.beckershospitalreview.com/supply-chain/abbott-warns-of-2-potential-safety-issues-with-its-heart-implant.html

Iterum’s sulopenem misses endpoint in cIAI study

Iterum Therapeutics (NASDAQ:ITRM) announces the results from a Phase 3 clinical trial, SURE 3, evaluating penem anti-infective sulopenem in patients complicated intra-abdominal infections (cIAI).

The trial (narrowly) missed the primary endpoint of clinical response at day 28 compared to ertapenem, thereby failing to demonstrate non-inferiority. Specifically, the 95% confidence interval required a lower limit of the difference in outcomes of no more than 10.0%. The results showed an interval of -10.3% to 1.0%.

On the safety front, the rates of treatment-related adverse events for sulopenem and ertapenem were 6.0% and 5.1%, respectively, with the most common being diarrhea, 4.5% and 2.4%, respectively. Serious adverse events were higher with sulopenem (7.5%) than ertapenem (3.6%) but the discontinuation rate was lower, 1.5% vs. 2.4%.

Topline data from another Phase 3 should be available next quarter. If positive, the company intends to proceed with a U.S. marketing application.

Shares down 48% after hours.

https://seekingalpha.com/news/3525352-iterums-sulopenem-misses-endpoint-in-ciai-study-shares-down-48-after-hours

Mednax shareholder Starboard may push for company sale

Mednax (NYSE:MD) activist investor Starboard Value has privately nominated a majority slate of directors at the healthcare services firm and is pushing for a full or partial sale of the company, WSJ reports.

Starboard submitted the slate ahead of Mednax’s nomination deadline a little over a week ago, according to the report, which also says Starboard could withdraw the slate if talks between the two sides result in an agreement but otherwise plans to move ahead with a proxy fight at the company’s annual meeting next year.

MD shares have slumped ~25% YTD, continuing a four-year slide, hurt by factors including higher expenses and a big goodwill impairment charge in the recent quarter.

https://seekingalpha.com/news/3525386-mednax-shareholder-starboard-may-push-for-company-sale-wsj

FDA panel thumbs down on Correvio’s Brinavess for afib

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voted 11-2 against approval of Correvio Pharma’s (NASDAQ:CORV) Brinavess (vernakalant hydrochloride, IV) for the rapid conversion of recent onset atrial fibrillation (AF) in adults.

Shares are currently halted, but longs should expect a significant down move upon resumption of trade.

https://seekingalpha.com/news/3525318-fda-advisory-committee-thumbs-down-on-correvios-brinavess-for-af

J&J appeals Oklahoma judge’s opioid ruling

Attorneys for Johnson & Johnson have appealed an Oklahoma judge’s order for the company to pay $465 million to address the state’s opioid crisis.

The company argues in an appeal filed Monday that the judge misapplied the state’s public nuisance laws in reaching his decision. The company also maintains that the award should be reduced by $355 million to offset pretrial settlements between the state and two other drugmakers.

“Without explanation, the court found Janssen liable for the entirety of a complex crisis implicating a multitude of criminal, governmental and medical actors,” attorneys wrote in a summary of the case. Janssen is the company’s pharmaceutical subsidiary.

The state of Oklahoma also plans to appeal the judge’s order, arguing that the $465 million it was awarded would only cover one year of its cleanup plan. The state has until Monday to file its appeal.

During the trial, state experts testified that it would cost about $17.5 billion over 30 years to abate the state’s opioid crisis. Attorneys for Johnson & Johnson maintain that figure is wildly inflated.

At the trial, the judge ruled that Johnson & Johnson and its subsidiaries helped fuel the opioid crisis by using an aggressive and misleading marketing campaign that understated the addiction risk of opioids and overstated their effectiveness in treating chronic pain.

Among the brands of opioid drugs the company produced and marketed were Duragesic, Ultram, Ultracet, Nucynta and Tylox. The company also owned two subsidiaries that produced much of the raw opium that other manufacturers used to make opioids.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-appeals-Oklahoma-judge-s-opioid-ruling-29708746/

Cigna in talks to sell non-health benefits unit to New York Life

New York Life Insurance is in negotiations to buy a unit from Cigna (CI -3%) that sells non-medical insurance products to employers in a deal that could be valued at as much as $6B, WSJ reports.

Potential buyers including MetLife (MET -0.6%) and Sun Life Financial (SLF +1%) also are vying for company, but New York Life recently emerged as the leading contender, according to the report, which says Cigna hopes to reach a deal by year-end.

Cigna is said to have been seeking a buyer for its business that sells life, accident and disability income insurance to employers for their workers, a move that would help the company focus on its core business.

https://seekingalpha.com/news/3525260-cigna-in-talks-to-sell-non-health-benefits-unit-to-new-york-life-wsj

Evolent Health up 11% on renewed hopes with Kentucky Medicaid contract

Evolent Health (EVH +11.3%) jumps on almost double normal volume in response to the news that the Kentucky legislature has voted against outgoing Governor Matt Bevin’s decision to award the state’s Medicaid contract to five insurers, excluding nonprofit Passport Health Plan [and Anthem (ANTM)] in favor of UnitedHealthcare (UNH +0.4%) and Molina (MOH -0.4%).

The about-face gives new life to Passport, which generates almost all of its $2B annual revenue from the state Medicaid contract, an acquisition target of Evolent’s.

Evolent shares plunged 34% in late November in response to Gov. Bevin’s action.

https://seekingalpha.com/news/3525255-evolent-health-up-11-on-renewed-hopes-kentucky-medicaid-contract