Technology | Defibrillator Monitors | March 10, 2017

Zoll Hospital Wearable Defibrillator Receives FDA Premarket Approval

Device continuously protects patients from cardiac arrest in the hospital

Zoll, Hospital Wearable Defibrillator, HWD, FDA premarket approval

March 10, 2017 — Zoll Medical Corp. announced that the company’s Hospital Wearable Defibrillator (HWD) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) to market and begin U.S. distribution of the device.

The Zoll HWD is specifically designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation (VT/VF) during their stay in the hospital. For a patient experiencing VT/VF, each minute that defibrillation is delayed increases the likelihood of dying or the likelihood of surviving with complications.

Through automatic detection and immediate treatment, the Zoll HWD provides patients at risk for VT/VF with continuous protection anytime day or night in the hospital. The device is an innovative tool for hospital care teams to manage patients at risk of VT/VF. Automatic detection and immediate treatment address the most critical factor for survival from cardiac arrest in these patients — timely defibrillation.

“The ability to provide hospitalized patients at risk for malignant ventricular arrhythmias a safe and effective device that enables rapid defibrillation represents a significant improvement in the care of cardiovascular patients,” said David M. Shavelle, M.D., associate clinical professor at Keck School of Medicine Division of Cardiology at the University of Southern California (USC), director of Los Angeles County (LAC) USC Cardiac Catheterization Laboratory, and director of General Cardiology Fellowship Program at USC.

The HWD helps the care team manage at-risk patients by detecting VT and VF. If a life-threatening rhythm is detected, the device alerts the patient prior to delivering a treatment shock, and thus allows a conscious patient to delay the treatment shock. The device is designed to deliver treatment within 60 seconds.

For more information: www.zoll.com

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init