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Friday, Mar 24, 2023

Regulators Grant New Edwards Sapien XT Clearance

Irvine-based Edwards Lifesciences Corp.’s Sapien XT replacement transcatheter heart valve gained another approval this month.

Edwards said the Food and Drug Administration granted it approval to use Sapien XT in pulmonic valve replacement procedures, enabling treatment of adult and pediatric patients who have narrowed pulmonary heart valves or greater pulmonary valve regurgitation caused by congenital heart disease.

The approval “provides an important, minimally invasive treatment option for a small group of patients who typically face the burden of multiple open-heart surgeries, oftentimes beginning at birth or during childhood,” said Larry Wood, Edwards’ corporate vice president, transcatheter heart valves.

Data from Edwards’ Compassion clinical trial and additional data from Europe was used to support the device maker’s approval bid.

Edwards first got FDA approval for Sapien XT in 2014. Since then, it’s been approved for a selection of procedures, including “valve-in-valve” ones during which a heart surgeon implants a transcatheter valve into a failed heart valve that was implanted via traditional open-heart surgery.

The Sapien family of heart valves, which also includes the Sapien 3 valve, accounted for $1.18 billion, or 47% of Edwards’ revenue last year. The device maker is Orange County’s largest public company, with a recent market value of $18.8 billion.

Chief Executive Michael Mussallem expressed optimism about Edwards’ transcatheter valve performance this year.

“Based on our momentum and expectation of continued therapy adoption, we now expect our underlying [transcatheter heart valve] sales growth in 2016 to be in the range of 15% to 25%,” he said.

Breast Health Provider Drawn to OC

West Los Angeles-based RadNet Inc. is increasing its Orange County presence through its Breastlink comprehensive breast centers.

RadNet opened a Breastlink last month in Newport Beach and is planning to open one more in a location to be determined late this year, said Norman Hames, the diagnostic radiation company’s chief operating officer.

Breastlink comprehensive centers are also in Laguna Hills and Orange, and the company has women’s imaging locations in Irvine, Santa Ana and Garden Grove.

The comprehensive centers provide imaging, breast-tumor surgery, breast oncology, and breast reconstructive surgery. The Newport Beach location is coupled with Finesse Plastic Surgery, a practice that provides surgical and nonsurgical procedures for breasts, face and body.

RadNet wanted to put Breastlinks in Orange County for several reasons, Hames said: “Patients are very well-educated, people understand their healthcare, people understand what’s going on with them.”

That couples with Breastlink’s business model, which Hames characterized as one “where patients are like partners. We take them every step of the way and educate them on the entire process.”

Hames added that RadNet’s core medical imaging business has been in OC for a number of years.

Breastlink is an in-network provider to health plans, according to Hames.

“We are not out of network. This is better for our patients,” he said. Reconstructive breast surgeons have traditionally been out-of-network providers, which require greater patient cost sharing.

RadNet competes with Newport Beach-based Alliance HealthCare Services Inc. in the diagnostic radiology and oncology space.

Vietnamese-American Health Probed

A California State University-Fullerton assistant professor will conduct a pilot study this spring focusing on the health of Vietnamese-American senior citizens in the county. Garden Grove and Westminster are among the cities with the largest Vietnamese populations in the U.S.

Yuying Tsong, assistant professor of human services, will assess seniors’ understanding of mental health challenges and how their cultural background may play into their willingness to seek professional help.

Tsong said in a news release that past studies showed Vietnamese-American seniors often suffer from post-traumatic stress disorder, possibly as a result of the Vietnam War. She added that those with limited English proficiency could avoid seeking help.

Tsong and her research assistant, CSUF graduate student Vi Pham, will present preliminary study findings at the American Psychological Association meeting in August.

Study participants will be interviewed in Vietnamese. The study is funded by two grants totaling $30,000 from the University of California-Los Angeles/Charles Drew University Resource Centers for Minority Aging Research/Center for Health Improvement of Minority Elderly and UCLA Clinical and Translational Science Institute.

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