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Saturday, Jul 2, 2022

Abbott Pacemaker System Receives FDA Approval

Abbott’s Cardiac Rhythm Management Division in Sylmar announced Monday that Aveir, the company’s single-chamber, leadless pacemaker system, has been approved by the U.S. Food and Drug Administration for the treatment of patients with slow heart rhythms.

The leadless pacemaker is the first of its kind to have a mapping capability to assess correct positioning prior to placement.

Aveir is implanted directly inside the right ventricle of the heart through a minimally invasive procedure that, unlike traditional pacemakers, does not require a chest incision.

“In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement,” Dr. Rahul Doshi, director of electrophysiology at Honor Health, said in a statement. “Abbott’s leadless pacemaker addresses the need for a single-chamber device that accommodates any therapy path for a patient through Aveir’s retrieval capability and extended battery longevity.”

Randel Woodgrift, senior vice president of Cardiac Rhythm Management at Abbott, said Aveir was designed with the goal of “revolutionizing how abnormal heart rhythms are treated.”

Shares of Abbott closed up 28 cents, or a fraction of a percent, to $118.86 on the Nasdaq Monday, a day when the closed up nearly 2 percent.

Antonio Pequeño IV
Antonio Pequeño IV
Antonio “Tony” Pequeño IV is a reporter covering health care, finance and law for the San Fernando Valley Business Journal. He specializes in reporting on some of the biggest names in the Valley’s biotechnology sector. In addition to his work with the Business Journal, Tony has reported with BuzzFeed News on the unsupervised use of Clearview AI, a controversial facial recognition technology. Tony, who also conducts freelance reporting, graduated from the USC’s Master of Science in Journalism program in 2021. He is in his fifth year as a journalist as of 2021.

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