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Tuesday, Mar 19, 2024
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Edwards Sapien Market Could Expand After Finding

Irvine-based Edwards Lifesciences Corp. recently shared data on yet another potential market for its Edwards Sapien less-invasive replacement heart valve.

Data analysis from the company’s Partner valve trial showed that diabetics with aortic stenosis who were at high surgical risk for complications during heart valve replacement surgery were 35% less likely to die one year after receiving a transcatheter valve compared with those who received a traditional replacement heart valve inserted through surgery, according to the company.

Aortic stenosis is a narrowing of the body’s main artery.

“While this was not a pre-specified analysis of the trial and should be considered hypothesis generating, our study raises the possibility that [transcatheter aortic valve replacement] may be the preferred approach for diabetic patients with severe symptomatic aortic stenosis who are at high surgical risk,” said Dr. Brian Lindman, an assistant professor of medicine at Washington University School of Medicine in St. Louis, in a news release.

Lindman, who participated as a clinical investigator in the Partner trial, presented the diabetic patient data at the European Society of Cardiology’s congress this month in Amsterdam.

Edwards Sapien is inserted on a beating heart through a catheter, eliminating the need for open-heart surgery. It’s considered one of the more significant cardiovascular device developments in recent years and is expected to open the market for patients who are too sick to have invasive surgery.

The Food and Drug Administration first approved Edwards Sapien in November 2011 for treating inoperable patients. Regulators then expanded the approval to high-risk surgical patients last October.

Transcatheter heart valve replacement, “as the preferred treatment for high-risk diabetic patients who suffer from aortic stenosis should expand Edwards’ addressable market,” Chicago-based Zacks Equity Research said in a report issued Sept. 4.

Zacks predicted domestic Sapien sales, which totaled $358.1 million through the first six months of the year, should accelerate in coming months, “given the exponential rise in incidence of diabetes.”

But the service noted that Edwards’ dominance in the transcatheter aortic valve replacement space “is likely to face challenges” as other companies “are slowly but steadily progressing well” with their transcatheter replacement valves.

Edwards’ competitors in the market include a pair of Minnesota-based companies with an Orange County presence: Medtronic Inc. and St. Jude Medical Inc.

Natick, Mass.-based Boston Scientific Corp. has a clinical trial for less-invasive heart valves that Zacks wrote was “progressing well.”

Alzheimer’s, Genetic Counseling Conferences

Orange County will be the site of two healthcare conferences in coming weeks focusing on topics that include genetic counseling and Alzheimer’s disease.

Genetic counseling involves helping people determine their risks for certain diseases and conditions.

More than 1,800 genetic counselors and other healthcare professionals interested in genomics and genetics will gather in Anaheim Oct. 9-12 at the National Society of Genetic Counselors’ annual educational conference. The Chicago-based professional society will meet at the Anaheim Convention Center.

Subjects include psychiatric genetics, developing genomics services, and why the history of genetic counseling matters.

On Sept. 20, “Countdown to 2025: Progress on Ending Alzheimer’s disease,” is taking place at the Hilton hotel in Costa Mesa. It’s sponsored by the University of California, Irvine’s Institute for Memory Impairments and Neurological Disorders and the Alzheimer’s Association’s Orange County chapter.

Some of the topics addressed include preventing the disease, best practices in diagnosis and treatment of Alzheimer’s, and stem cell therapies. About 600 people are expected to attend.


Auxilio Expands Sutter Contract

Mission Viejo-based Auxilio Inc. said it has a new five-year contract with Sutter Health East Bay Region, a unit of Sacramento-based Sutter Health.

Auxilio offers print management services to help hospitals and other healthcare providers cut their dependence on paper records.

Its new contract includes Alta Bates Summit Medical Center in Berkeley and Oakland; Eden Medical Center; Sutter Delta Medical Center; and the Sutter East Bay Medical Foundation.

Auxilio has worked with Sutter since 2005, when it first introduced its program at San Francisco-based California Pacific Medical Center, which is part of Sutter Health’s West Bay region.

Bits and Pieces

The government of India recently revoked Irvine-based Allergan Inc.’s patents for its Ganfort and Combigan glaucoma drugs. India has been aggressive in rebuking and revoking patents sought by Western drug companies seeking a bigger share of the country’s fast-growing, $13 billion drug market. … Irvine-based healthcare software maker Kareo Inc. said it topped a list of electronic health records, practice management and revenue cycle management software vendors published by Black Book Rankings, a division of Clearwater, Fla.-based Black Book Market Research LLC. Black Book’s study is based on input from more than 8,000 doctors and medical-practices staff surveyed between April and July, according to Kareo.

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