News | May 01, 2012

FDA Panel Recommends Approval of Cameron Health's Subcutaneous S-ICD System


May 1, 2012 — Cameron Health Inc. announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD (subcutaneous-implantable cardioverter defibrillator) system for the treatment of sudden cardiac arrest (SCA).

"We are pleased with the panel's strong recommendation for approval of the S-ICD system, the world's first and only completely subcutaneous ICD for the treatment of sudden cardiac arrest," said Kevin Hykes, president and CEO of Cameron Health. "This represents another important step on the path toward FDA approval of the S-ICD system and its availability to physicians and their patients at risk for sudden cardiac arrest."

Cameron Health submitted a premarket approval application (PMA) in December 2011 based on data from a 330-patient pivotal investigational device exemption (IDE) clinical study that evaluated the safety and efficacy of the S-ICD system in patients at risk of SCA.

"The S-ICD system is a breakthrough technology that holds promise as a new alternative for treating patients at risk for sudden cardiac arrest," said Michael R. Gold, professor of medicine and chief of cardiology at the Medical University of South Carolina. "The S-ICD system provides the same defibrillation protection as conventional ICDs, but without the serious complications associated with leads that reside in the heart and blood vessels."

On March 8, 2012, Boston Scientific Corp. announced that it would exercise its option to acquire Cameron Health. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

For more information: www.cameronhealth.com

Related Content

Feature | Implantable Cardioverter Defibrillator (ICD) | By Dave Fornell, Editor

February 2, 2020 — The U.S. Food and Drug Administration (FDA) has identified a recent recall of the Boston Scientific ...

Home February 02, 2021
Home
News | Implantable Cardioverter Defibrillator (ICD)

January 8, 2020 — A new study published this week in HeartRhythm, the journal of the Heart Rhythm Society (HRS), found ...

Home January 08, 2021
Home
News | Implantable Cardioverter Defibrillator (ICD)

May 8, 2020 — Final results from the UNTOUCHED study of the Emblem Subcutaneous Implantable Defibrillator (S-ICD) System ...

Home May 08, 2020
Home
Feature | Implantable Cardioverter Defibrillator (ICD)

May 8, 2020 — A new clinical trial is the first to compare the safety and efficacy of subcutaneous implantable ...

Home May 08, 2020
Home
News | Implantable Cardioverter Defibrillator (ICD)

October 11, 2019 — Medtronic plc announced the start of a worldwide pivotal study evaluating its investigational ...

Home October 11, 2019
Home
News | Implantable Cardioverter Defibrillator (ICD)

September 18, 2019 — Early use of an implantable cardioverter-defibrillator (ICD) after primary coronary intervention ...

Home September 18, 2019
Home
Feature | Implantable Cardioverter Defibrillator (ICD) | Dave Fornell, Editor

This is a brief overview of updates on implantable cardioverter defibrillators (ICD), including new technology ...

Home May 24, 2019
Home
News | Implantable Cardioverter Defibrillator (ICD)

May 13, 2019 — Boston Scientific announced acute results from the UNTOUCHED study evaluating safety and efficacy of the ...

Home May 13, 2019
Home
News | Implantable Cardioverter Defibrillator (ICD)

August 9, 2018 — Medtronic plc announced the start of a pilot study of its investigational Extravascular Implantable ...

Home August 09, 2018
Home
Feature | Implantable Cardioverter Defibrillator (ICD)

July 11, 2018 — Placement of implantable cardioverter defibrillators (ICDs) not meeting Centers for Medicare and ...

Home July 11, 2018
Home
Subscribe Now