Sudden cardiac death (SCD) is often overlooked by the general public – most people think it is simply another term, or fancy expression, for a heart attack. The fact is, the two are very different and require different treatments based on the severity of the patient.Vicor Technologies Inc. (OTCBB: VCTR), a biotechnology and medical device company developing breakthrough diagnostic and therapeutic products, believes it has come up with a product that can fill the unmet needs of those suffering from cardiac ailments. The product is the Vicor PD2i Cardiac Analyzer.
This technology is designed to enable physicians to group patients into two categories, low risk and high risk, in hopes of customizing treatments for the severity of the problem.
To understand the importance of this product, David Fater, CEO of VCRT, said the public needs to understand the difference from a heart attack and SCD.
Fater explains that a heart attack is like a plumbing problem, where the blood to the heart is choked off.
SCD is caused by a breakdown of the normal neurological communication pattern between the heart and the brain, more like an electrical problem. This can lead to a deadly heart rhythm effect in minutes if left untreated.
Fater said the problem is that there are too many people being treated for this type of ailment.
“Right now there are 12 million people in the United States that meet the current criteria for the implantation of a cardiac defibrillator,” Fater explained. “These people often times won’t have a defibrillator implanted because of a variety of reasons such as insurance.”
Of the patients that use the defibrillator, 76 percent have never received a shock from the defibrillator, which means they didn’t really need it.
“The current clinical criteria for who gets a defibrillator and who doesn’t are based on two large trials that were paid for by the defibrillator companies, and they are not precise criteria,” Fater said.
This is the precise reason that VCRT felt it necessary to implement its new technology.
The PD2i analyzes 1000 heartbeats and is able to accurately put users into high or low risk categories based on the Patients EKG. The company claims that this doesn’t involve a stress test, has minimal to no risk to the patient, and is very easy to use.
The “vital” trial of PD2i is underway and being coordinated by Harvard Clinical Research Institute and Target Health, which will involve 700 to 900 patients in 30 sites around the country. By the end of the month VCRT expects to have at least 15 of these sites up and running.
“We are estimating that the current clinical trial will take approximately 18 to 24 months to complete,” Fater added. “Based on results we could be recommended to go straight to FDA during the middle of the trial.”
Fater concluded that the team of doctors working on the product is of the top tier, coming from solid backgrounds in the medical field.
“Our inventing scientist is Dr. James Skinner,” Fater noted, “who was the first PHD neuroscientist out of UCLA.” He spent 23 years as a professor of medicine at Baylor University and at the DeBakey Heart Institute with Dr. Michael E. Debakey.
Apparently it was Skinners discovery that the heart and brain are connected that led to the basis of the company’s technology.
With the pool of people meeting the current criteria growing 5 percent a year from 12 million, VCRT believes this is a very necessary product that could pinpoint who needs treatment, as well as the severity of the problem for each specific individual.
