Cameron Health
Encyclopedia
Cameron Health is a medical device
developer based in San Clemente, California
, USA. Cameron Health has its European office, Cameron Health BV, in Arnhem
, The Netherlands. The privately-held company's focus is on a new generation of minimally invasive implantable cardioverter-defibrillator
(ICD) which they call a Subcutaneous Implantable Defibrillator (S-ICD). Cameron Health's approach avoids implanting transvenous leads into the heart
, which has been the usual procedure for cardiac devices. Instead, the Cameron ICD is entirely implanted outside the thoracic wall.
The Cameron Health subcutaneous ICD sits outside the ribcage and has no connection to the interior of the heart. The surgical procedure for implantation is minimally invasive as opposed to the traditional procedure of threading leads into the subclavian venous system, through the superior vena cava
and into one or more endocardial areas of the heart, a procedure often requiring a cardiologist with specialized training in electrophysiology
. In addition to the risks inherent in cardiac surgery, the leads have themselves proved to be a weakness in some ICD designs. According to one estimate, patients with ICDs have a 20 percent chance of lead failure within 10 years, and replacing the leads carries a risk of death of between 2 and 5 percent. Some device manufacturers have had to replace defective leads which exposed implanted individuals to unnecessary shocks or other malfunctions, in some cases possibly resulting in fatalities.
The Cameron Health S-ICD has the disadvantage of being somewhat bulkier than existing ICDs. Also, this kind of ICD does not include a pacemaker, which narrows the range of patients for whom it would be appropriate; it is estimated that a majority of patients now receiving combination pacemaker/ICD implants would qualify for a pure ICD. These patients tend to have genetic or other conditions predisposing them to sudden cardiac death due to a failure of the heart of maintain a normal rhythm.
Congress.
A second series of 55 trial patients was conducted in 2008 and 2009 in 10 centers in Europe
and New Zealand
. Of the 55 patients, 53 had two instances of fibrillation
and in 52 these were successfully converted. These findings were reported to European Union authorities in 2009, and resulted in approval for marketing the device. A study of 300 patients is in progress for US approvals. Small nonrandomized early-phase studies primarily intended to show the feasibility of an entirely subcutaneous ICD were updated, combined and published in May 2010. In this report, the system successfully and consistently detected and converted episodes of ventricular fibrillation that were induced during electrophysiological testing. In the European trial of 55 patients, after 46 patient-years of follow-up, 54 of 55 patients were alive, and the single death was due to renal failure. In this trial the system successfully detected and treated 12 episodes (100%)of spontaneous, sustained ventricular tachyarrhythmia in three patients, prior to the onset of syncope, and with no adverse events. One of the three patients was successfully treated for seven successive episodes of ventricular tachycardia, a condition known as a "VT storm".
acquired an exclusive option to purchase Cameron Health in 2004, and made an undisclosed equity investment in the company at that time.
In 2008, several additional investors organized by the investment company Piper Jaffray
and including PTV Sciences, Delphi Ventures, Sorrento Ventures, Three Arch Partners and Versant Ventures provided just over $50 million to finance the continuing operation of the company.
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
developer based in San Clemente, California
California
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
, USA. Cameron Health has its European office, Cameron Health BV, in Arnhem
Arnhem
Arnhem is a city and municipality, situated in the eastern part of the Netherlands. It is the capital of the province of Gelderland and located near the river Nederrijn as well as near the St. Jansbeek, which was the source of the city's development. Arnhem has 146,095 residents as one of the...
, The Netherlands. The privately-held company's focus is on a new generation of minimally invasive implantable cardioverter-defibrillator
Implantable cardioverter-defibrillator
An implantable cardioverter-defibrillator is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect cardiac arrhythmia and correct it...
(ICD) which they call a Subcutaneous Implantable Defibrillator (S-ICD). Cameron Health's approach avoids implanting transvenous leads into the heart
Heart
The heart is a myogenic muscular organ found in all animals with a circulatory system , that is responsible for pumping blood throughout the blood vessels by repeated, rhythmic contractions...
, which has been the usual procedure for cardiac devices. Instead, the Cameron ICD is entirely implanted outside the thoracic wall.
Reasons for a minimally invasive approach
Every ICD is designed to detect heart rhythms consistent with a catastrophic failure of the body's natural regulation of the heartbeat, which, untreated, could result in death. When an ICD detects a serious arrhythmia, it issues an electrical impulse to the heart muscle, of a magnitude sufficient to cause the heart to revert to a normal rhythm. ICDs with transvenous leads administer this shock to the interior of the heart muscle; the Cameron Health device generates a more powerful shock which can be effective from outside the heart. In the view of Cameron Health, transvenous leads into the heart needlessly complicate the process of implanting a device, and raises other issues and risks which their less invasive approach avoids.The Cameron Health subcutaneous ICD sits outside the ribcage and has no connection to the interior of the heart. The surgical procedure for implantation is minimally invasive as opposed to the traditional procedure of threading leads into the subclavian venous system, through the superior vena cava
Superior vena cava
The superior vena cava is truly superior, a large diameter, yet short, vein that carries deoxygenated blood from the upper half of the body to the heart's right atrium...
and into one or more endocardial areas of the heart, a procedure often requiring a cardiologist with specialized training in electrophysiology
Electrophysiology
Electrophysiology is the study of the electrical properties of biological cells and tissues. It involves measurements of voltage change or electric current on a wide variety of scales from single ion channel proteins to whole organs like the heart...
. In addition to the risks inherent in cardiac surgery, the leads have themselves proved to be a weakness in some ICD designs. According to one estimate, patients with ICDs have a 20 percent chance of lead failure within 10 years, and replacing the leads carries a risk of death of between 2 and 5 percent. Some device manufacturers have had to replace defective leads which exposed implanted individuals to unnecessary shocks or other malfunctions, in some cases possibly resulting in fatalities.
The Cameron Health S-ICD has the disadvantage of being somewhat bulkier than existing ICDs. Also, this kind of ICD does not include a pacemaker, which narrows the range of patients for whom it would be appropriate; it is estimated that a majority of patients now receiving combination pacemaker/ICD implants would qualify for a pure ICD. These patients tend to have genetic or other conditions predisposing them to sudden cardiac death due to a failure of the heart of maintain a normal rhythm.
Clinical trials and approvals
A trial involving 53 patients, who were temporarily implanted with S-ICDs, was reported in 2005 at the European Society of CardiologyEuropean Society of Cardiology
The European Society of Cardiology is a membership organisation of more than 70,000 cardiology professionals across Europe and the Mediterranean. It is involved in scientific and educational activities for cardiology professionals and also promotes cardiovascular disease prevention messages to the...
Congress.
A second series of 55 trial patients was conducted in 2008 and 2009 in 10 centers in Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
and New Zealand
New Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...
. Of the 55 patients, 53 had two instances of fibrillation
Fibrillation
Fibrillation is the rapid, irregular, and unsynchronized contraction of muscle fibers. An important occurrence is with regards to the heart.-Cardiology:There are two major classes of cardiac fibrillation: atrial fibrillation and ventricular fibrillation....
and in 52 these were successfully converted. These findings were reported to European Union authorities in 2009, and resulted in approval for marketing the device. A study of 300 patients is in progress for US approvals. Small nonrandomized early-phase studies primarily intended to show the feasibility of an entirely subcutaneous ICD were updated, combined and published in May 2010. In this report, the system successfully and consistently detected and converted episodes of ventricular fibrillation that were induced during electrophysiological testing. In the European trial of 55 patients, after 46 patient-years of follow-up, 54 of 55 patients were alive, and the single death was due to renal failure. In this trial the system successfully detected and treated 12 episodes (100%)of spontaneous, sustained ventricular tachyarrhythmia in three patients, prior to the onset of syncope, and with no adverse events. One of the three patients was successfully treated for seven successive episodes of ventricular tachycardia, a condition known as a "VT storm".
Financing
Boston ScientificBoston Scientific
The Boston Scientific Corporation , is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention,...
acquired an exclusive option to purchase Cameron Health in 2004, and made an undisclosed equity investment in the company at that time.
In 2008, several additional investors organized by the investment company Piper Jaffray
Piper Jaffray
Piper Jaffray & Co. , often shortened to just Piper Jaffray or PiperJaffray, is a U.S. middle-market investment banking firm based in Minneapolis, Minnesota, and sells financial advice, investment products, and transaction execution within targeted sectors of the financial services marketplace...
and including PTV Sciences, Delphi Ventures, Sorrento Ventures, Three Arch Partners and Versant Ventures provided just over $50 million to finance the continuing operation of the company.