Arizona Arrhythmia Consultants Investigating New ICD Technology Announces Progress In Development Of Novel Defibrillation Therapy for US Patients

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Commercially available ICD technology gets closer to offering life-saving therapy to patients at risk of sudden cardiac arrest in the United States.

Partner of Arizona Arrhythmia Consultants

Thomas Mattioni, MD, FACC

What makes this life-saving technology really exciting is the fact that it is unlike anything we have today. The Cameron Health Implantable Cardiac Defibrillator does not require an electrical wire to be placed inside the heart.

THOMAS MATTIONI, MD, FACC, a Principal Investigator for Cameron Health Inc. in Arizona and Director of the Cardiac Electrophysiology Program at Scottsdale Healthcare and senior consulting clinical electrophysiologist with Arizona Arrhythmia Consultants (AAC), announced today that the Cameron Health Implantable Cardiac Defibrillator (S-ICD) life saving therapy that AAC has been investigating for nearly two years may be on the horizon for U.S. Sudden Cardiac Arrest patients.
Reuters reported on Thursday March 8th, 2012 that Boston Scientific Corp has agreed to acquire Cameron Health, a company that has been developing an innovative treatment technology for primary prevention of Sudden Cardiac Death.

“What makes this life-saving technology really exciting is the fact it is unlike anything we have today. The Cameron Health Implantable Cardiac Defibrillator S-ICD is the only system that does not require an electrical wire to be placed inside the heart, leaving the heart and blood vessels untouched and intact,” said Dr. Mattioni.

“Today conventional therapy requires thin, insulated wires (leads) to pass through the venous system and into the heart,” commented Dr. Mattioni. “Overtime we’ve seen that the wire in the heart is the weak link in current ICD systems because the heart beats approximately 100,000 times a day and there’s a lot of mechanical stress put on the transvenous electrical wire. The Cameron Health technology is designed to eliminate the complications associated with transvenous lead wires, creating an important new treatment option.”

Lead failure can result in potentially catastrophic ICD malfunctions. As recently as December 2011, St Jude Medical, a global medical device manufacturer announced that the US Food and Drug Administration (FDA) had classified its high powered leads, the Riata® and Riata® ST Silicone Defibrillation Leads, as a Class One Recall. In October, 2007, Medtronic issued a recall of its Fidelis ICD lead, which has been responsible for multiple ICD malfunctions due to accelerated lead failure.

“There is no clear consensus on how to manage affected recalled transvenous leads,” reported Dr. Mattioni. “However, it is recommended these patients be evaluated and closely monitored so that a treatment plan can be initiated related to these “high risk” leads. But young patients may need the wire to function normally for many years. This new breakthrough treatment could one day be a first line option.”

Even without directly touching the heart, the Cameron S-ICD shock can reset the heart’s normal rhythm and uses an ECG-like signal to monitor for indications of sudden cardiac arrest. The S-ICD system is designed to accurately treat sudden cardiac arrest when needed.

“My implant experience with the product has been very good,” Dr.Mattioni said. “This new category of rhythm management devices for sudden cardiac arrest will offer physicians a new first line therapy for appropriate patients.”

Boston Scientific exercised its option to acquire Cameron Health Inc, a privately held company based in San Clemente, California on March 8th, 2012. The acquisition of the first and only commercially available subcutaneous (under the skin) implantable cardioverter defibrillator – the S-ICD® System builds on Boston Scientifics’ portfolio of medical devices for cardiac rhythm management.

Cameron Health applied for U.S. approval in December and is currently going through the US regulatory process. The Cameron Health S-ICD System has already received a CE mark in Europe and has been commercially available in major European countries since 2009 and sold in several countries around the world, with more than one thousand patients having received the devices. The S-ICD® System is restricted under Federal law for investigational use only and is not for sale in the U.S.

ARIZONA ARRHYTHMIA CONSULTANTS has a reputation of excellence in delivering the highest quality comprehensive cardiac electrophysiology care. As the premiere Cardiac Electrophysiology (EP) practice in Arizona, AAC physicians are on the forefront of EP technologies and clinical research nationwide focused on heart arrhythmias. They are regarded as the leading authority and innovators throughout the state of Arizona in the research and practice of Clinical Electrophysiology.

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Stacey Rorvig
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