Technology | September 03, 2009

Zoll Receives FDA Clearance for New LifeVest Model


September 3, 2009 – ZOLL Medical Corp. received approval from the FDA to market and sell a new model of the LifeVest wearable defibrillator.

The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), allowing their physicians time to assess their long-term arrhythmic risk and make appropriate plans, including potentially the decision to implant a cardioverter defibrillator (ICD). The LifeVest is lightweight and easy to wear, allowing patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. Today more than 2,000 patients are currently wearing the LifeVest.

“With the FDA approval of this additional LifeVest model, we are increasing inventory levels to provide improved customer service to support our continued growth,” said Richard A. Packer, chairman and chief executive officer of ZOLL. “The flexibility to grow inventory in response to business needs positions us well to execute our aggressive field force expansion to reach our goal of 86 representatives in the U.S. by fiscal year-end... We are pleased to be able to focus on meeting physicians’ needs for this lifesaving therapy for their patients.”

The LifeVest is rented to patients like other durable medical equipment, allowing physicians to provide the patient the protection of the LifeVest by placing a medical order directly with ZOLL. From this point, ZOLL manages the process to protect the patient from sudden cardiac arrest from hospital discharge to recovery at home, including fitting the LifeVest to the patient, educating the patient in the hospital prior to release, managing all of medical documentation and insurance paperwork, and addressing via telephone and in person any patient needs once home.

For more information: www.zoll.com

Related Content

News | Defibrillator Monitors

June 23, 2020 — Philips announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for ...

Home June 23, 2020
Home
News | Defibrillator Monitors

April 24, 2020 — The U.S. Food and Drug Administration (FDA) has lifted its injunction prohibiting the manufacturing and ...

Home April 24, 2020
Home
News | Defibrillator Monitors

January 13, 2020 — Stryker announced it is launching a voluntary field action on specific units of the LifePAK 15 ...

Home January 13, 2020
Home
Technology | Defibrillator Monitors

June 19, 2019 — Philips announced the U.S. Food and Drug Administration (FDA) has approved the company’s premarket ...

Home June 19, 2019
Home
News | Defibrillator Monitors

April 5, 2019 — Medical device startup HeartHero was the winner in the Innovation Challenge at the 2019 American College ...

Home April 05, 2019
Home
Feature | Defibrillator Monitors

February 4, 2019 — Stryker announced Feb. 1, the company is launching a voluntary field action on specific units of the ...

Home February 04, 2019
Home
Feature | Defibrillator Monitors | Michael J. Mirro, M.D.

Following the Vest Prevention of Early Sudden Death Trial (VEST) presentation at the 2018 American College of Cardiology ...

Home July 10, 2018
Home
News | Defibrillator Monitors

June 27, 2018 — Wearable cardioverter defibrillators may be a safe and effective alternative to surgically implanted ...

Home June 27, 2018
Home
News | Defibrillator Monitors

April 16, 2018 — The skin presents a formidable barrier to life-saving defibrillators, but a team of students from Rice ...

Home April 16, 2018
Home
News | Defibrillator Monitors

October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ...

Home October 16, 2017
Home
Subscribe Now