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Tuesday, May 5, 2026

OC Insider: Matters of Heart

Edwards Lifesciences on April 23 reported that its largest business, transcatheter aortic valve replacement (TAVR),  generated Q1 sales of $1.2 billion, an 11% increase over the prior year (NYSE: EW).

CEO Bernard Zovighian is bullish on the best-known product for OC’s most valuable public company, noting on an earnings call that “there has been a shift toward proactive disease management with an increased focus on evaluation and intentional referral of patients” suffering from heart valve disease.

That optimism stands in stark contrast to a recent fear-mongering feature in the Wall Street Journal, which asserted that the company’s “breakthrough heart procedure comes with risky tradeoffs.”

The April 23 story suggested that the artificial valves used by Irvine-based Edwards and competitor Medtronic in TAVR, a far less invasive surgery procedure than open-heart surgery, and one which results in much faster recovery times, “don’t work as well or last as long as they hoped,” particularly for patients under 65.

Edwards officials dispute the story’s claims, telling the Business Journal that it “presents a narrow and misleading portrayal of a highly specialized patient population and does not reflect the full body of scientific evidence.”

Zovighian noted in the Q1 conference call that recent 7- and 10-year follow-up studies “validate the durability and consistent performance” of Edwards’ TAVR products.

The Insider’s questions: why was the WSJ story timed to coincide with Edwards’ earnings, and which company whose products compete with TAVR pitched the story to the publication?

Shares in the $47B-valued company were flat in the week following the Q1 results.

In early 2021, Masimo founder and then-CEO Joe Kiani penned a Leader Board for the Business Journal titled “Pulse Oximeters Are Not Racist” (Nasdaq: MASI).

Kiani’s article hit back at claims made in a late 2020 New England Journal of Medicine article, titled “Racial Bias in Pulse Oximetry Measurement,” that highlighted a report showing challenges facing Black patients using the devices made by Masimo and others that monitor blood oxygen saturation and pulse rates.

Data cited in the report indicated non-white skin tones produced substantially less accurate readings in the devices, which increased the risk of delayed or inaccurate treatment for those patients.

Masimo testing “found a difference between dark and light skinned subjects of 1%, whereas that same test applied in the (study cited in the New England journal) found a 325% difference,” Kiani noted. Masimo would do additional testing to confirm the validity of its findings, he said at the time.

Some of those results are now in, and they back up Kiani’s claims.

Masimo last week reported new study data showing that its pulse oximetry technology accurately monitored hospitalized newborns of all skin tones, following what it called “the largest-ever prospective real-world study of its kind.”

Later this year, Masimo said that it will publish data from another study involving 500 critically ill adult ICU patients of all skin tones.

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Mark Mueller
Mark Mueller
Mark is the former Editor-in-Chief and current Community Editor of the Orange County Business Journal, one of the premier regional business newspapers in the country. He’s the fifth person to hold the editor’s position in the paper’s long history. He oversees a staff of about 15 people. The OCBJ is considered a must-read for area business executives. The print edition of the paper is the primary source of local news for most of the Business Journal’s subscribers, which includes most of OC’s major corporate and community players. Mark’s been with the paper since 2005, and long served as the real estate reporter for the paper, breaking hundreds of commercial and residential real estate stories. He took on the editor’s position in 2018.

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