Irvine-based device maker Edwards Lifesciences Corp. (NYSE: EW), while best known as one of the pioneers in less-invasive transcatheter heart valves, also has a strong focus in critical-care patient monitoring. The company recently received Food and Drug Administration approval to launch its acumen hypotension prediction index, a software that alerts clinicians of potential low blood pressure in surgical patients.
“Even brief periods of hypotension are associated with complications, or worse, death, after surgery,” said Dr. Maxime Cannesson, professor and vice chairman of the department of anesthesiology and perioperative medicine at the University of California-Los Angeles.
The software, designated as a supplemental predictive cardiovascular indicator, is compatible only with Edwards’ minimally invasive hemodynamic monitoring device. It was created based on data from more than 200,000 patient events.
Separately, the device maker completed enrollment in a substudy that examines leaflet mobility of both the Sapien 3 valve and surgical valve in low-risk patients undergoing valve replacement for the treatment of severe aortic stenosis. The randomized study, which assigns patients with either a transcatheter valve replacement or surgery, will compare the data from the two groups at the conclusion of the study.
In addition, Edwards is studying the SAPIEN 3 Ultra System, which is not on the market. It plans to enroll up to 30 intermediate-risk patients.
Patient monitoring device maker Masimo Corp. (Nasdaq: MASI) continues to expand remote monitoring capability, recently announcing the release of Replica, an application for smartphones and tablets that enables clinicians to view continuous monitoring data for multiple patients from their smartphones.
Masimo got FDA clearance for the home use of Rad-97 in January. The device, with an optional integrated camera, allows clinicians to monitor and interact with patients over live audio and video.
CHOC Donation
Children’s Hospital of Orange County received a $3 million gift to support programs and activities focused on adolescents and young adults treated for cancer at the Hyundai Cancer Institute. The gift came from Corona del Mar couple Rich and Ginnie Hunsaker, who have a history of supporting CHOC.
The program, geared toward teens and young adults with cancer, provides weekly social activities, including movie nights and art classes, as well as events like an oncology prom, peer support groups, college counseling and application assistance and weekend retreats.
It will be named the Richard C. and Virginia A. Hunsaker adolescent and young adult oncology child life program.
Kara Noskoff, program child life specialist, said a cancer diagnosis interrupts adolescence and that the program is designed to “reduce the risks of depression and feelings of isolation … we want our patients to not only survive, but to thrive.”
The Hunsakers have also supported the hospital’s mental health initiative—an 18-bed inpatient program for children ages 3 to 18 with mental health issues—and general oncology child life program. The center is scheduled to open this week (see story, page 3).
“We feel so privileged to be able to support the inspiring ways CHOC is helping adolescents and young adults with cancer,” Ginnie Hunsaker said. “These young men and women should not have to miss out on all of the milestones that are unique to their age, and important to their future.”
Rich is a native of Long Beach and made his fortune in real estate. He launched Hunsaker Management Inc. in Irvine in the 1960s.
Bits & Pieces
University of California-Irvine MIND, OC’s only state and federally funded Alzheimer’s disease and research center, has partnered with Lyft to provide free rides to clinical trial participants and their family members. The rides are made possible through a new partnership between the Global Alzheimer’s Platform Foundation, of which UCI MIND is a member, and the on-demand transportation company. … Irvine-based Hoag Memorial Hospital Presbyterian plans to add an 18,000-square-foot maternity services unit, whose construction will start next year. The 12-suite unit will allow low-risk pregnant women to labor, deliver and recover in the same room, which will have a family-centered design and home-like amenities, according to the hospital.
