Cameron Health

Last updated
Cameron Health
Company typePrivately held
Industry Medical technology
Founded2000
FounderGust Bardy, MD and Riccardo Cappato, MD
DefunctJune 8, 2012 (2012-06-08) [1]
FateAcquired
Successor Boston Scientific
Headquarters San Clemente, California, United States
Key people
Kevin Hykes, President and CEO
ProductsSubcutaneous Implantable cardioverter-defibrillator
Website www.cameronhealth.com

Cameron Health was a medical device developer based in San Clemente, California, US. Cameron Health had its European office, Cameron Health BV, in Arnhem, The Netherlands. The privately held company's focus was on a new generation of minimally invasive implantable cardioverter-defibrillator (ICD) which they called a Subcutaneous Implantable Defibrillator (S-ICD). Cameron Health's approach avoided implanting transvenous leads into the heart, which had been the usual procedure for cardiac devices. Instead, the Cameron ICD was entirely implanted outside the thoracic wall.

Contents

In June 2012, Boston Scientific acquired Cameron Health for a total sum of $1.3 Billion, paid out incrementally as various revenue milestones were achieved. [1] As of February 2016, Boston Scientific still markets the S-ICD system. [2]

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 generated a more powerful shock which can be effective from outside the heart. In the view of Cameron Health, transvenous leads into the heart needlessly complicated the process of implanting a device, and raised other issues and risks which their less invasive approach avoids. [3]

The Cameron Health subcutaneous ICD sat outside the ribcage and has no connection to the interior of the heart. The surgical procedure for implantation was 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. [4] In addition to the risks inherent in cardiac surgery, the leads have themselves proved to be a weakness in some ICD designs. [5] 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 two and five percent. [6] 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. [7] [8]

The Cameron Health S-ICD had the disadvantage of being somewhat bulkier than existing ICDs. [6] Also, this kind of ICD did not include a pacemaker, which narrowed the range of patients for whom it would be appropriate; it was estimated that a majority of patients receiving combination pacemaker/ICD implants would qualify for a pure ICD. These patients tended to have genetic or other conditions predisposing them to sudden cardiac death due to a failure of the heart of maintain a normal rhythm. [9]

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 Cardiology Congress. [10] 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. [6] [11] 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 Scientific acquired an exclusive option to purchase Cameron Health in 2004, and made an undisclosed equity investment in the company at that time. [12] In 2008, several additional investors organized by the investment company Piper Jaffray [13] and including PTV Healthcare Capital, Delphi Ventures, Sorrento Ventures, Three Arch Partners and Versant Ventures provided just over $50 million to finance the continuing operation of the company. [14]

In June 2012, Boston Scientific officially acquired Cameron Health for a total sum of $1.3 Billion, paid out incrementally as various revenue milestones were achieved. [1]

Related Research Articles

<span class="mw-page-title-main">Artificial cardiac pacemaker</span> Medical device for artificially stimulating heart contractions

An artificial cardiac pacemaker, commonly referred to as simply a pacemaker, is an implanted medical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to contract and pump blood, thus regulating the function of the electrical conduction system of the heart.

<span class="mw-page-title-main">Cardioversion</span> Conversion of a cardiac arrhythmia to a normal rhythm using an electrical shock or medications

Cardioversion is a medical procedure by which an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia is converted to a normal rhythm using electricity or drugs. Synchronized electrical cardioversion uses a therapeutic dose of electric current to the heart at a specific moment in the cardiac cycle, restoring the activity of the electrical conduction system of the heart. Pharmacologic cardioversion, also called chemical cardioversion, uses antiarrhythmia medication instead of an electrical shock.

<span class="mw-page-title-main">Defibrillation</span> Treatment for life-threatening cardiac arrhythmias

Defibrillation is a treatment for life-threatening cardiac arrhythmias, specifically ventricular fibrillation (V-Fib) and non-perfusing ventricular tachycardia (V-Tach). A defibrillator delivers a dose of electric current to the heart. Although not fully understood, this process depolarizes a large amount of the heart muscle, ending the arrhythmia. Subsequently, the body's natural pacemaker in the sinoatrial node of the heart is able to re-establish normal sinus rhythm. A heart which is in asystole (flatline) cannot be restarted by a defibrillator; it would be treated only by cardiopulmonary resuscitation (CPR) and medication, and then by cardioversion or defibrillation if it converts into a shockable rhythm.

<span class="mw-page-title-main">Implantable cardioverter-defibrillator</span> Medical device

An implantable cardioverter-defibrillator (ICD) or automated implantable cardioverter defibrillator (AICD) is a device implantable inside the body, able to perform defibrillation, and depending on the type, cardioversion and pacing of the heart. The ICD is the first-line treatment and prophylactic therapy for patients at risk for sudden cardiac death due to ventricular fibrillation and ventricular tachycardia.

<span class="mw-page-title-main">Short QT syndrome</span> Medical condition

Short QT syndrome (SQT) is a very rare genetic disease of the electrical system of the heart, and is associated with an increased risk of abnormal heart rhythms and sudden cardiac death. The syndrome gets its name from a characteristic feature seen on an electrocardiogram (ECG) – a shortening of the QT interval. It is caused by mutations in genes encoding ion channels that shorten the cardiac action potential, and appears to be inherited in an autosomal dominant pattern. The condition is diagnosed using a 12-lead ECG. Short QT syndrome can be treated using an implantable cardioverter-defibrillator or medications including quinidine. Short QT syndrome was first described in 2000, and the first genetic mutation associated with the condition was identified in 2004.

<span class="mw-page-title-main">Ventricular tachycardia</span> Abnormally fast rhythm of the hearts ventricles

Ventricular tachycardia is a cardiovascular disorder in which fast heart rate occurs in the ventricles of the heart. Although a few seconds of VT may not result in permanent problems, longer periods are dangerous; and multiple episodes over a short period of time are referred to as an electrical storm. Short periods may occur without symptoms, or present with lightheadedness, palpitations, shortness of breath, chest pain, and decreased level of consciousness. Ventricular tachycardia may lead to coma and persistent vegetative state due to lack of blood and oxygen to the brain. Ventricular tachycardia may result in ventricular fibrillation (VF) and turn into cardiac arrest. This conversion of the VT into VF is called the degeneration of the VT. It is found initially in about 7% of people in cardiac arrest.

<span class="mw-page-title-main">Cardiac electrophysiology</span> Science of elucidating, diagnosing, and treating the electrical activities of the heart

Cardiac electrophysiology is a branch of cardiology and basic science focusing on the electrical activities of the heart. The term is usually used in clinical context, to describe studies of such phenomena by invasive (intracardiac) catheter recording of spontaneous activity as well as of cardiac responses to programmed electrical stimulation - clinical cardiac electrophysiology. However, cardiac electrophysiology also encompasses basic research and translational research components. Specialists studying cardiac electrophysiology, either clinically or solely through research, are known as cardiac electrophysiologists.

<span class="mw-page-title-main">T wave alternans</span> Periodic variation in the T wave of an electrocardiogram

In cardiology, T wave alternans (TWA) is a periodic beat-to-beat variation in the amplitude or shape of the T wave in an electrocardiogram . TWA was first described in 1908. At that time, only large variations could be detected. Those large TWAs were associated with increased susceptibility to lethal ventricular tachycardias.

St. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries. Its major markets include the United States, Europe, Latin America and Asia-Pacific. The company was named after Jude the Apostle, the patron saint of lost causes.

Clinical cardiac electrophysiology, is a branch of the medical specialty of cardiology concerned with the study and treatment of rhythm disorders of the heart. Cardiologists with expertise in this area are usually referred to as electrophysiologists. Electrophysiologists are trained in the mechanism, function, and performance of the electrical activities of the heart. Electrophysiologists work closely with other cardiologists and cardiac surgeons to assist or guide therapy for heart rhythm disturbances (arrhythmias). They are trained to perform interventional and surgical procedures to treat cardiac arrhythmia.

<span class="mw-page-title-main">Transcutaneous pacing</span> Method of temporary stabilizing an individuals heartbeat

Transcutaneous pacing (TCP), also called external pacing, is a temporary means of pacing a patient's heart during a medical emergency. It should not be confused with defibrillation using a manual or automatic defibrillator, though some newer defibrillators can do both, and pads and an electrical stimulus to the heart are used in transcutaneous pacing and defibrillation. Transcutaneous pacing is accomplished by delivering pulses of electric current through the patient's chest, which stimulates the heart to contract.

Morton Maimon Mower was an American cardiologist specializing in electrophysiology and the co-inventor of the automatic implantable cardioverter defibrillator. He served in several professional capacities at Sinai Hospital and Cardiac Pacemakers Inc. In 1996, he became the chairman and chief executive officer of Mower Research Associates. He was inducted into the National Inventors Hall of Fame in 2002 for the development of the automatic implantable cardioverter defibrillator with Michel Mirowski in the 1970s. He continued his research in the biomechanical engineering laboratories at Johns Hopkins University.

Alois A. Langer is an American biomedical engineer best known as one of the co-inventors of the Implantable Cardioverter Defibrillator (ICD).

<span class="mw-page-title-main">Cardiac resynchronization therapy</span> Treatment for heart failure

Cardiac resynchronisation therapy is the insertion of electrodes in the left and right ventricles of the heart, as well as on occasion the right atrium, to treat heart failure by coordinating the function of the left and right ventricles via a pacemaker, a small device inserted into the anterior chest wall.

A wearable cardioverter defibrillator (WCD) is a non-invasive, external device for patients at risk of sudden cardiac arrest (SCA). It allows physicians time to assess their patient's arrhythmic risk and see if their ejection fraction improves before determining the next steps in patient care. It is a leased device. A summary of the device, its technology and indications was published in 2017 and reviewed by the EHRA Scientific Documents Committee.

Cardiac contractility modulation is a therapy which is intended for the treatment of patients with moderate to severe heart failure with symptoms despite optimal medical therapy who can benefit from an improvement in cardiac output. The short- and long-term use of this therapy enhances the strength of ventricular contraction and therefore the heart's pumping capacity by modulating (adjusting) the myocardial contractility. This is provided by a pacemaker-like device that applies non-excitatory electrical signals adjusted to and synchronized with the electrical action in the cardiac cycle.

<span class="mw-page-title-main">Yaariv Khaykin</span> Canadian cardiologist

Yaariv Khaykin is a Canadian cardiologist and a clinical researcher in the area of electrophysiology. He is the director of the Newmarket Electrophysiology Research Group at the Southlake Regional Health Centre. He has published research into complex ablation and pioneered cardiac ablation methods.

<span class="mw-page-title-main">Cardiac Pacemakers, Inc.</span>

Cardiac Pacemakers, Inc. (CPI), doing business as Guidant Cardiac Rhythm Management, manufactured implantable cardiac rhythm management devices, such as pacemakers and defibrillators. It sold microprocessor-controlled insulin pumps and equipment to regulate heart rhythm. It developed therapies to treat irregular heartbeat. The company was founded in 1971 and is based in Saint Paul, Minnesota, and is presently a subsidiary of Boston Scientific.

<span class="mw-page-title-main">Subcutaneous implantable defibrillator</span>

Subcutaneous implantable cardioverter defibrillator, or S-ICD, is an implantable medical device for detecting and terminating ventricular tachycardia and ventricular fibrillation in patients at risk of sudden cardiac arrest. It is a type of implantable cardioverter defibrillator but unlike the transvenous ICD, the S-ICD lead is placed just under the skin, leaving the heart and veins untouched.

Cyborg data mining is the practice of collecting data produced by an implantable device that monitors bodily processes for commercial interests. As an android is a human-like robot, a cyborg, on the other hand, is an organism whose physiological functioning is aided by or dependent upon a mechanical/electronic device that relies on some sort of feedback.

References

  1. 1 2 3 "Boston Scientific Closes Cameron Health Acquisition". PR Newswire. UBM PLC. 8 June 2012. Retrieved 26 February 2016.
  2. ↑ "EMBLEM S-ICD System". Boston Scientific. Archived from the original on 26 February 2016. Retrieved 26 February 2016.
  3. ↑ Bardy GH, Smith WM, Hood MA, Crozier IG, et al. (May 2010). "An Entirely Subcutaneous Implantable Cardioverter–Defibrillator" (PDF). N. Engl. J. Med. 363 (1). New England Journal of Medicine: 36–44. doi:10.1056/NEJMoa0909545. PMID   20463331.
  4. ↑ Meier, Barry (April 21, 2009). "Study Backs Specialists Implanting Heart Devices". New York Times. Retrieved 19 January 2010.
  5. ↑ Jaeger, Fredrick J. "Cardiac Arrhythmias". Cleveland Clinic. Retrieved 19 January 2010.
  6. 1 2 3 Graham-Rowe, Duncan (November 26, 2008). "Internal External Defibrillator". Technology Review. MIT. Retrieved 19 January 2010.
  7. ↑ Meier, B. (March 13, 2009). "Medtronic Links Device for Heart to 13 Deaths". New York Times. Retrieved 19 January 2010.
  8. ↑ Burton, Thomas M. (4 February 2010). "Hospitals Dispute Medtronic Data on Wires". Wall Street Journal. pp. D6.
  9. ↑ Meier, Barry (13 May 2010). "Under-Skin Defibrillators Seen Closer to Reality". The New York Times.
  10. ↑ Stiles, Steve (December 4, 2008). "ICDs with subcutaneous leads may be just around the corner". The Heart. Retrieved 19 January 2010.
  11. ↑ O'Riordan, Michael (May 18, 2009). "Subcutaneous ICD system detects and terminates induced ventricular fibrillation". The Heart. Retrieved 19 January 2010.
  12. ↑ "Stent Company Invests in Defibrillator Maker". Los Angeles Times/Bloomberg News. February 21, 2004. Archived from the original on October 21, 2012. Retrieved 19 January 2010.
  13. ↑ "Transactions: 50 million raised 05/08". Piper Jaffray. Retrieved 19 January 2010.
  14. ↑ "Cameron Health Gets $51.5 Million Injection". New York Times. June 17, 2008. Retrieved 19 January 2010.
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