Vicor Tech (VCRT) - Huge Support for SCD Indication - Analyst Blog

Brian Marckx, CFA

Vicor Tech (VCRT) - Huge Support for SCD Indication
 
There was an interesting article in the January 4, 2011 edition of the Wall Street Journal that brings to light the significant issue of over-implantation (or perhaps under-implantation) of defibrillators.  Over-implantation can unnecessarily put patients at risk of dying on the operating table and contributes to skyrocketing health care costs (these are expensive medical devices).  Under-implantation means people can unnecessarily die from sudden cardiac death.  Both have potentially very serious consequences and are part of the reason why we are on the Vicor Technologies (VCRT) bandwagon.      

The article, titled “Many Defibrillator Patients Don't Meet Guidelines, Study Finds”  (which can be accessed here http://online.wsj.com/article/SB10001424052748704723104576062033805309132.html) cited a study sponsored by the National Heart Lung and Blood Institute which found that almost 23% of implantable-defibrillator patients failed to meet medical guidelines to receive the devices, some of which would likely never benefit from it.  Most of these patients were typically considered too sick (as a result of a recent heart-attack or heart failure) to risk complications that could arise with the invasive surgery required to implant the device in a person's chest, especially in patients where the potential benefit from a defibrillator is questionable.  Guidelines call for waiting to implant a defibrillator in these patients to see if the patient's condition will improve.   

The team that led the study was quoted in the article as saying, “While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has demonstrated no benefit.”  

Boston Scientific, one of the largest producers of cardiac defibrillators (ICDs), countered that many people that die from sudden cardiac death (SCD) could have been saved with an implantable defibrillator, but didn't receive one.  The company noted, “that on the whole, this life-saving therapy is under-utilized, rather than over utilized.”    

Clearly there is a need for a better determinant of who and who should not get an implantable defibrillator.  Ralph Brindis, president of the American College of Cardiology, was quoted in the article as saying, this study will "have major implications for physicians and hospitals in their evaluation of their practice patterns."   

This is where Vicor comes in.  Vicor has shown in clinical trials that its PD2i Analyzer may the most accurate technology in the prediction of SCD.  Sudden cardiac death is a very scary deal -  it is the most common cause of natural death in the U.S., accounting for 400,000 fatalities every year.  Roughly 90% of victims that experience SCD symptoms die.

While ICDs have shown to be very effective in terminating arrhythmias and tachycardias, only a small portion of SCD victims were fitted with an ICD at the time of SCD onset.  It has also been shown that the vast majority of people who have been fitted with an ICD will not suffer from the onset of SCD and therefore, may have been inappropriately diagnosed as at-risk of experiencing sudden cardiac death.  A meta-analysis of two clinical studies (Cost-Effectiveness of Implantable Cardioverter-Defibrillators October 2005 and Amiodarone or an Implantable Cardioverter-Defibrillator for Congestive Heart Failure January 2005) that were published in The New England Journal of Medicine showed that 76% of patients which were identified as at-risk of suffering from near-term SCD, in fact did not experience symptoms of an SCD episode (i.e. the ICD was not needed).

Vicor s PD2i® algorithm may be the most accurate and effective technology in predicting the risk of near-term sudden cardiac death and directly addresses the issues of over- and under-implantation of ICD.  The company has demonstrated the efficacy of the PD2i® technology in several self-sponsored trials as well as a collaborative study with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. This latter study was the basis for the July 1, 2010 510(k) filing seeking a claim for the identification of congestive heart failure patients at elevated risk of cardiac mortality.

We cover Vicor with an Outperform rating and $1.07 price target.  See the link below for access to our 26 page report on the company which includes a discussion of how the PD2i Analyzer could revolutionize the guidelines used to determine who should receive an implantable defibrillator.  

For a copy of the full report, please email SCR@zacks.com with VCRT as the subject.