The Latest Cardiology News

With the cardio-centric EuroPCR conference fast approaching, now is a good time to note some of the latest developments in the cardiovascular space:

Cameron Health has released positive clinical trial data on a unique therapy to prevent sudden cardiac arrest, a leading cause of death in the U.S. The S-ICD System is the first minimally invasive, subcutaneous implantable cardiac defibrillator for the treatment of sudden cardiac arrest. Results from four studies were published online in the New England Journal of Medicine (NEJM).

Patients with sudden cardiac arrest experience a sudden loss of heart function caused by an “electrical” malfunction of the heart. If the malfunction persists, the patient almost always loses consciousness and dies. Sudden cardiac arrest is fatal in 95 percent of cases. The condition can be treated by implanting a transvenous implantable cardioverter device (ICD), which requires one or more electrical leads to be placed around the heart, usually by threading the leads through blood vessels. If  the ICD detects a harmful arrhythmia, the device administers a life-saving shock to restore the heartbeat to its normal state. However, the leads can become surrounded by tissue, and they can be difficult to repair or replace if the need arises.

The S-ICD System is implanted just under the skin, eliminating the need for lead placement. Researchers conducted two short-term trials designed to assess energy requirements and identify a suitable device configuration, and two longer-term trials to assess the efficacy of the system in detecting and treating cardiac arrhythmias. The device was found to be as effective as traditional ICDs, although the energy requirements were approximately three times greater. The S-ICD system successfully detected 100 percent of induced arrhythmias in addition to 100 percent of spontaneous ventricular tachyarrhythmias, with 98 percent of patients satisfying implant testing criteria. The complications and risks of the S-ICD are the same as any ICD, which can be bleeding at the site where the device was implanted and infection. A larger 330-patient trial began in the U.S. in March.

The trials took place between 2001 and 2009 at 17 medical centers in 7 countries. “Underneath the simplicity of the therapy is an extremely sophisticated technology that has taken the effort of many hundreds of talented people over 9 years to develop,” states Dr. Gust H. Bardy, M.D., head of the Seattle Institute for Cardiac Research and the principal author of the NEJM paper. Some of the biggest challenges faced by researchers included identifying a device configuration, developing a robust detection system, and ensuring the safe treatment of all research subjects.

Patients with congenital heart disorders who are at risk for sudden death, or patients who develop a transvenous lead system failure in which removing the failed lead would be too risky, may be strong candidates for the device. Considering that sudden cardiac arrest kills hundreds of thousands per year in the U.S., with similar numbers in other countries, Bardy believes that the market for the S-ICD system could be sizable, particularly if a larger U.S. trial validates the effectiveness of the device: “[The S-ICD System] may prove a welcome alternative to physicians that sometimes struggle with complications and complexity related to transvenous systems.” The S-ICD System is approved for use in Europe. According to Bardy, Cameron Health plans to expand the use of the S-ICD System in Europe and complete the U.S. trial.

Another company, Cerenis Therapeutics, recently announced positive Phase I study data for its drug candidate to treat acute coronary syndromes. CER-001 was found to be safe and well-tolerated at all dose levels evaluated. The drug demonstrated cholesterol-removing properties, consistent with pre-clinical findings.

CardiAQ Valve Technologies has successfully used its proprietary transcatheter delivery system to deliver a self-anchoring, self-conforming mitral heart valve implant in an animal model. The company plans to discuss this milestone in a presentation at EuroPCR. CVT is focused on developing a minimally invasive alternative to open-heart surgery for treating mitral valve regurgitation.

Finally, Abbott Laboratories plans to present data at EuroPCR on four clinical trials of cardiovascular devices in development. One of the devices to be discussed is a bioresorbable vascular scaffold designed to restore blood flow to the heart by opening up a clogged vessel. Once the vessel is able to remain open independently, the scaffold dissolves and is absorbed into the body.

Other companies working in this space include:

CryoCor, developer of a disposable catheter system for the cryotherapeutic treatment of arrhythmias, atrial fibrillation, and atrial flutter. Cryotherapy can be used to ablate, or destroy, tissue associated with arrhythmias.

Evaheart Medical USA, maker of an artificial heart that is currently undergoing a clinical trial.

Hypertension Diagnostics, innovator of a non-invasive system to measure the elasticity of the small and large arteries. Studies have shown that patients with diseases such as hypertension, heart failure, coronary artery disease and diabetes exhibit a loss of arterial elasticity.

Sunshine Heart, which develops cardiac assist devices for patients with long-term moderate to severe heart failure. The company’s C-Pulse device is designed to fulfill the unmet clinical needs between CRT pacemakers and end-stage-therapy.

What are some other interesting cardiovascular device developments you’ve heard of recently?

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