Medically speaking, this may be — borrowing a line from poet Robert Frost — "the road less traveled."
This particular road is the human esophagus, and the traveler is the Hickey Cardiac Monitoring System (HCMS), being developed by emerging med-tech company Scivanta Medical (Spring Lake, New Jersey).
The goal of the journey: to provide the primary measurements of cardiac performance in a less-invasive and more cost-effective manner.
David LaVance, CEO of Scivanta, told Medical Device Daily that its HCMS technology, rather than acquiring cardiac measurement data by invading an artery, capitalizes on the "unique anatomical relationship of the esophagus and the left atrium," because "the esophagus runs just in front of the spine between the spine and the heart."
Scivanta licensed the technology, LaVance said, in November from the University of Buffalo (Buffalo, New York) where Donald Hickey, MD, spent 12 years developing it.
Though LaVance noted that though Scivanta has been around for more than two decades as a medical device distributor, it headed down the broader path to product development about three years ago with the focus to acquire and develop technologies with advantages over existing procedures and treatments.
The HCMS is a minimally-invasive cardiac monitoring device using an esophageal two-balloon catheter that provides cardiac performance data similar to that obtained through pulmonary artery catheters (PACs), such as the Swan-Ganz catheter. According to the company, the device addresses many of the shortcomings of PACs, by bringing minimally-invasive cardiac monitoring technology to intensive care units and to cardiology, surgical and anesthesia markets — with the minimally invasive route being very much more traveled in medicine these days.
Because Swan-Ganz and other PACs must be inserted through an artery by a trained physician, the use of these devices is limited to critical care settings, Scivanta says.
In addition to the usual risks associated with cardiac catheterization, such as infection and pneumothorax (compressed lung), studies have suggested that patients undergoing monitoring with PACs have significantly greater mortality during hospitalization due to the invasive nature of these procedures.
According to Scivanta, there is a "considerable lack of consensus on how to use the readouts from a Swan-Ganz catheter and which relevant clinical parameters the device actually measures."
With the HCMS, once the caregiver positions the catheter, the balloons are inflated. Wall motion in the left atrium and aorta generates pressure changes in the respective balloons. The electronic monitoring system connected to the catheter records signals from these pressure changes as well as data from an electrocardiogram (ECG), phonocardiogram, and automated blood pressure cuff. The monitoring system then translates the raw data into relevant, real-time clinical measurements, the company said.
Although the catheter can be inserted through the patients' mouth and down the throat, LaVance said it would most likely be inserted through the nose, similar to a nasogastric (NG) tube, which is passed through the nose and down the esophagus into the stomach. Because no surgery is required, a physician, nurse or medical technician can do the insertion.
LaVance said Scivanta is still in the development-stage with its HCMS. He estimates launch of clinical trials with the technology in about nine months.
The HCMS is Scivanta's first product, but LaVance said the company is looking for other technologies that meet its acquisition criteria: products or technologies that have significantly progressed through the development stage and where very little, if any, research on the product or technology remains.
"We're looking for technologies that allow physicians — clinical practitioners — to do cardiac monitoring or other procedures more easily, quickly, better, cheaper, and with less risk to the patient," LaVance said.
Last week Scivanta reported that it has received the final payment of $2.55 million from Syntho Pharmaceuticals (Farmingdale, New York) and its principal owner, Muhammed Malik (collectively, the Synthro Group), related to a settlement entered into among Scivanta, the Synthro Group and other related parties on Nov.22, 2006. LaVance said the funds will be used for working capital purposes and to support development of the HCMS (Medical Device Daily, April 2, 2007).
Scivanta is hoping to stand apart from other companies in the cardiac monitoring sector with the HCMS technology, and LaVance guessed the market for this product to be as large, or larger, than the Swan-Ganz market, which he estimated at about $200 million.
Scivanta said it believes that taking a less-invasive route with its cardiac monitoring system will result in the device being used in applications outside of surgical and intensive care settings. Perhaps that will make — as Frost might say — "all the difference" for this emerging med-tech company.