Endologix Inc. (Nasdaq: ELGX) needs to nail down product quality. The Irvine-based medical device company named Jeffrey Fecho chief quality officer following a recent safety alert from the Food and Drug Administration indicating “the Endologix AFX with Strata device is at great risk for a Type III endoleak compared to other endovascular AAA graft systems.”
The agency recommends, based on the finding, that providers should “closely monitor patients who have previously undergone implantation with the AFX with Strata device.”
The new position is “a critical role within our company as we strive to make continuous improvements to our processes and products,” said Chief Executive John Onopchenko in a press release. Fecho was most recently division vice president of operations and new product quality at Abbott Laboratories (NYSE: ABT) after serving as vice president of global quality at St. Jude Medical Inc.
Endologix develops minimally invasive products used to treat abdominal aortic aneurysm, or thinning of a blood vessel wall. Ruptured abdominal aortic aneurysms are the leading cause of death in the U.S. and the 10th-leading cause of death in men older than 55, according to the Society of Vascular Surgery. Products are in endovascular aneurysm repair and endovascular sealing.
Endologix has had its challenges. Onopchenko joined the company in October as chief operating officer after the FDA recalled the company’s AFX abdominal aortic aneurysms system, and there was a temporary CE mark suspension over reports of Type III endoleaks in an older version of the device. He was promoted to head the company in May, succeeding former Chief Executive John McDermott.
Onopchenko was previously executive vice president of Carlsbad-based Acutus Medical Inc.
European CE mark for Endologix’ product line was reinstated last year in January, and the company quickly addressed manufacturing issues resulting from a manufacturing glitch at its Irvine plant, according to Securities and Exchange Commission filings.
The company is shifting focus this year from the AFX line to the Ovation endovascular sealing system in the U.S., according to an earlier earnings call. It’s also seeking FDA approval of its other sealing device, the Nellix stent graft.
Shares of the company recently traded at $5.80 each for a $479 million market cap.
Space for Care
The Business Journal reported late last month that Easterseals Southern California received a $1.75 million gift from the David and Molly Pyott Foundation. Proceeds will be used to pay off the former Santa Ana corporate office’s mortgage and to renovate the site to create a new adult day services location. ESSC relocated its corporate offices to Irvine.
Molly is ESSC board chairwoman. Her husband, David, is a philanthropist and former Allergan chief executive.
The nonprofit assists more than 10,000 adults with disabilities or other special needs in Los Angeles, Orange, San Diego, Imperial, Kern, San Bernardino, Riverside and Ventura counties. Services include adult/senior day services, autism therapy and employment services.
Molly said the expansion will allow activities such as group exercise and cooking, “[creating] profoundly positive differences for people with disabilities in our community.”
David said that paying off the mortgage ensures future donations will go toward supporting the organization and its work.
ESSC announced it’s naming the renovated center after the Pyotts.
The new adult day services center is scheduled to open next year.
New Operator
This month, the city of Long Beach and the MemorialCare Health System, former operator of Community Medical Center Long Beach, finalized an agreement to transition the operations of the medical facility, reopening it as soon as possible.
MemorialCare announced the hospital’s closure in March due to a study released last summer showing the facility, which includes an emergency room, wouldn’t meet seismic safety standards by a June 2019 deadline. The city owns the property; the Fountain Valley-based health system has operated the community hospital since 2011.
The city named Molina, Wu, Network LLC as the new facility operator last month. MemorialCare submitted a request to the state health department to suspend its license to operate the facility, allowing Molina, Wu, Network to temporarily take over. The new group still needs a license to act as an operator.
MemorialCare has agreed to help the city and Molina to reopen the hospital. MemorialCare is allowed to keep operating its outpatient facilities on the community hospital campus.
