News | March 22, 2010

Leadless ICD Begin FDA Clinical Trial


March 22, 2010 – A pivotal clinical trial recently began to gain U.S. approval for a defibrillator system that does not have any leads in or on the heart. Additionally, no imaging equipment is required for placement of the system, since all of the components are positioned using anatomical landmarks.

Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently they are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and long-term implantation of these transvenous leads are associated with a significant proportion of the complications related to this therapy. In contrast, the Cameron Health Subcutaneous Implantable Defibrillator (S-ICD) System resides just under the skin, potentially avoiding many of these lead complications.

The trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at six months for patients at risk of sudden cardiac arrest (SCA).

The IDE trial will involve patients at centers in the U.S., Europe and New Zealand. The first IDE implants were performed in New Zealand by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in the U.S. were performed by Martin Burke, M.D., director of the Heart Rhythm Center at the University of Chicago.

“Given the simplicity of the implantation I can see the potential to reduce the surgical and long term complications inherent in transvenous ICD systems,” Dr. Burke said. The first U.S. patient to receive Cameron Health’s S-ICD System was Brooke Bergeron, 38, who suffered a heart attack during the birth of her fourth child. Her doctors recommended an implantable defibrillator due to heart damage that put her at risk for SCA.

Components of the S-ICD System include the SQ-RX Pulse Generator, Q-TRAK Subcutaneous Electrode, Q-GUIDE Electrode Insertion Tool and the Q-TECH Programmer. The S-ICD System is implanted subcutaneously (just under the skin) with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through a highly advanced integrated programming system developed specifically for the S-ICD System.

The S-ICD System received CE approval in 2009 and is commercially available in Europe.

For more information: www.cameronhealth.com


Related Content

News | Cardiovascular Clinical Studies

February 26, 2024 — More than 6 million Americans live with heart failure, and about half have an enlarged left ...

Home February 26, 2024
Home
News | Cardiovascular Clinical Studies

February 21, 2024 — An 80-year-old woman from Frankenmuth, Michigan is the first Henry Ford Health structural heart ...

Home February 21, 2024
Home
News | Cardiovascular Clinical Studies

February 15, 2024 — Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and ...

Home February 15, 2024
Home
News | Cardiovascular Clinical Studies

January 3, 2024 — Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of ...

Home January 03, 2024
Home
News | Cardiovascular Clinical Studies

December 19, 2023 — Peerbridge Health has announce the successful completion and findings of its prospective ...

Home December 19, 2023
Home
News | Cardiovascular Clinical Studies

December 14, 2023 — Published results of a large, national heart attack study show that patients with a life-threatening ...

Home December 14, 2023
Home
News | Cardiovascular Clinical Studies

December 11, 2023 — A world without cardiovascular disease (CVD) is possible, yet millions of lives are lost prematurely ...

Home December 11, 2023
Home
News | Cardiovascular Clinical Studies

December 8, 2023 — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac ...

Home December 08, 2023
Home
Subscribe Now