Zoll Medical (Chelmsford, Massachusetts) has received FDA approval to market and sell a new model of its LifeVest wearable defibrillator. The device is intended for patients at risk for sudden cardiac arrest (SCA), allowing their doctors time to assess their long-term arrhythmic risk and make appropriate plans, including potentially the decision to implant a cardioverter defibrillator, Zoll said.

The FDA approved the first generation LifeVest in 2002, but it was not fully available commercially until 2005. The new model is the fourth generation of the device.

"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 Packer, CEO and chairman 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."

Packer told Medical Device Daily that the market demand for LifeVest has been growing "very quickly." He said in the first half of this year the demand for the device grew in excess of 70% compared to a year ago, so the increased supply of equipment is an important part of this new model of the LifeVest being approved.

"The fourth generation is a little bit smaller and a little bit lighter than previous generations, it also has more automation in terms of when a patient downloads information from the device and sends it to their physician, they used to have to plug into a phone line, now it's all wireless," Packer said. "The fourth generation and previous two generations – the 3000 and the 3100 – will all co-exist in the market place together."

According to the company, 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. More than 2,000 patients are currently wearing the LifeVest, Zoll said.

Zoll said 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 the company. From this point, Zoll says it manages the process to protect the patient from SCA 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.

"This kind of temporary risk of cardiac arrest, there are an awful lot of patients that fall into this category that are essentially unprotected when they leave the hospital," Packer said. He estimated that the total market potential for the LifeVest is $1.8 billion.

Earlier this year Zoll reported that its LifeVest is now covered by the three largest state Medicaid programs in the country – California, New York and Texas – which combined represent a total of more than 13 million covered lives (Medical Device Daily, Jan. 16, 2009). The company noted at that time that the device has a 98% first shock success rate for treating patients with SCA. In addition, no bystander intervention is required, the company said. The technology continuously monitors the patients' heart and, if a life-threatening heart rhythm is detected, the device alerts the patient prior to delivering a shock. The vest releases a conductive gel onto the therapy electrodes to protect the skin, and then delivers a shock to restore normal heart rhythm. The entire event, from detecting the arrhythmia to delivering a defibrillation shock, usually happens in less than a minute, Zoll said.

With products for pacing, defibrillation, circulation, temperature management, and fluid resuscitation, Zoll says it provides a comprehensive set of technologies, including Real CPR Help and See-Thru CPR, which help clinicians, EMS professionals, and lay rescuers resuscitate SCA or trauma victims. Zoll also designs software that automates the documentation and management of both clinical and non-clinical information, the company noted.

Amdanda Pedersen, 229-471-4212; amanda.pedersen@ahcmedia.com