Medical Device Daily Executive Editor

ORLANDO — Are the exhibition areas at these big conferences getting swankier, the exhibits bigger and glitzier, the walk-away swag ever more enticing?

Well, maybe not the swag, but the exhibition area of the scientific sessions of this year’s American Heart Association (AHA; Dallas) gathering did seem to feature extra-plush carpeting, the big-company layouts as big as cruise ships and some of the more innovative product presentations that we’ve seen — the most interesting being of the non-invasive sort.

For instance:

• Though still a start-up, Itamar (Germantown, Maryland) scored a coup at the meeting, reporting a key role in a Framingham Heart Study, using the company’s Endo-PAT (Peripheral Arterial Tone) technology which provides a measure of endothelial dysfunction signaling cardiovascular risk, cholesterol, blood pressure and too much weight.

A product of Israeli research, Endo-PAT is a 15-minute test, featuring what look like large thimbles placed on the index fingers of both hands, a basic blood pressure (BP) cuff on the arm used to provide a “provocation” to the vasculature, with wave forms then taken before and after the provocation. A ratio of before-and-after wave forms close to 2.0 indicates little risk, close to 1.0 indicating a high risk.

The ratio is a measurement of mechanical vaso-motion changes, which, according to Koby Sheffey, one of the system’s inventors, gives an assessment of endothelial function that may indicate microvascular dysfunction and cardiovascular disease risk.

The data from the Framingham Heart Study showed a significant association between Endo-PAT measurement and several risk factors. Additionally, three other oral presentations were presented at the AHA meeting, from Britain and Sweden, showing the relevance of endothelial function assessment with the Endo-PAT in other conditions in children and adults.

Sheffey told Medical Device Daily that about 180 studies have been published on the Endo-PAT since its FDA approval in 2003 — the four years since then being used to demonstrate efficacy. And he said he believes this to be the largest ratio of clinical studies to early-stage, small-company development.

Sheffey said that the measurement of endothelial function is increasingly seen as an important marker for early risk as part of a growing emphasis on heart disease as largely systemic — not a problem of just one or another discrete cardiovascular organ or organ system.

Thus far, Itamar has marketed the Endo-PAT primarily to researchers, but that it was using the AHA meeting to launch promotion for widespread clinical use for the early assessment of cardiovascular disease.

A medical conference exhibit enables a company to demonstrate its system with a live person, and in this case a young cardiologist was on hand to take the test, telling MDD that it produced no sensation other than an awareness of pulsing in his fingers. He was able to relax, sitting comfortably in a chair and receive early confirmation of no great cardiac risk (though the wave form did detect a possible small pre-beat arrhythmia).

• Then there was Kent Scientific (Torrington, Connecticut), developer of animal-handling systems for research use, the company exhibiting one of these — for taking the BP of rats.

This suggests a variety of amusing images: a teeny-tiny blood pressure cuff and a lab technician chasing down the rat in his cage and talking it into holding still long enough to wrap the cuff around the rat’s arm ... er leg.

Hardly the case for this system, though a tiny BP cuff is used, placed not on a leg but on the base of the rat’s tail.

The animal sits in a rat-sized-diameter clear plastic tube, his head in a cone-shaped “Elizabethan collar” so it is not distracted (white-coat-syndrome-wise, say), with the tube then closed behind, the tale sticking out for BP cuff placement.

And there’s no rat-chasing involved.

Following system purchase, the company supplies a consultant who shows you how to train the rats to walk into the tube – or tubes, since the system can be provided with multiple tubes of the same or different sizes, from big-rat-size, to mouse-size.

The BPs are used to determine the cardiovascular effects of drugs or other procedures on the rats, and the strategy involved is an important alternative to the previous standard of telemetry, Joel Malkoff of Kent, told MDD.

Use of telemetry is invasive because requiring an incision in the rat to place some sort of sensor, which then sends wireless signals to a monitor collecting the data.

Malkoff noted that the use of Kent’s non-invasive system keeps PETA from picketing at your front door and saves considerable dollars, since the system does not harm the rat and the BPs can be taken from the same animal for different therapies and at various stages of its growth.

Malkoff said that all of the major drug developers have purchased the system. And a cardiologist visitor to the Kent exhibit told MDD that the measurements taken are accurate and key to establishing research baselines.

• On the therapeutic side, Medispec (Germantown, Maryland) was exhibiting its Cardiospec system for non-invasive treatment of angina using a shock wave.

Gil Hakim, cardiovascular business line manager for Medispec, said that the shock-wave technique is the same as that used in lithotripsy but only at one-tenth the power.

The shock, guided by ultrasound, is directed to “the muscles of the heart that are ischemic,” he told MDD, to trigger “natural angiogenesis,” the creation of additional blood vessels in the heart.

The treatments are 15 minutes in length, delivered in three phases: three times the first month, three times month five, three times month nine.

Cardiospec received the CE mark three years ago, and Medispec is now pointed toward winning FDA premarket application approval next year.

Hakim’s emphasis was on the non-invasiveness of the system, saying that some patients may feel a little warmth around the heart area but that there are “no side effects and no damage” to the heart.

In trials, the perfusion effect results in improvements in exercise tolerance, reduction in medication use and improved quality of life, Hakim told MDD.

The feedback from patients, he said, is that “they call their friends” and tell them about their improvement with the system and don’t want to return to previous therapies.