Medical Device Daily

SAN DIEGO — Walking through the exhibit hall this week at the Society of Thoracic Surgeons (Chicago) 43rd annual meeting, attendees were greeted with about 120 booths adorned with a plethora of large, flashy posters illustrating a variety of new devices targeting the cardiothoracic market, each booth manned by company representatives more than eager to talk about their latest products.

And while the booths demonstrating new high-tech machines — like the new CS300 automatic IAB (intra-aortic balloon) pump from Datascope Cardiac Assist (Montvale, New Jersey), or the Thermogard temperature management system from Alsius (Irvine, California) — drew their fair share of attention, some of the smaller products on display proved to be just as interesting.

For example, one of the new products Kimberly-Clark (Dallas) showed off at its STS exhibit booth was its InteguSeal Microbial Sealant, a film-forming liquid designed to reduce surgical site infections.

“It’s new to the world,” Ajay Houde, PhD, an engineer in the company’s product and technology development department, told Medical Device Daily. “As you prep the skin you apply a thin layer [of the sealant] and it seals and immobilizes bacteria.”

Because many of the clinical studies that have been done with the product have involved pigs, the company even had two pig’s feet on display at its booth for demonstrations. But Houde said InteguSeal has also been used on 9,000 patients in the U.S. and has been available in Europe for about 10 months.

“It works with all different preps, it does not wash off during the procedure, and it stays on for three to seven days and then comes off on its own,” Houde said.

According to Kimberly-Clark, infection at the surgical site remains the second most adverse event occurring to hospitalized patients and a major source of morbidity following operating procedures.

While a booth operated by a plastic surgeon was unexpected at a conference geared towards cardiothoracic surgeons, Tadeusz Wellisz, MD, from the University of Southern California, (Los Angeles) told MDD why his company’s product, Ostene, would be useful to cardiac surgeons.

Ostene, a water-soluble, odorless, opaque wax-like material consisting of a sterile mixture of alkylene oxide copolymers, made by ceremed (Los Angeles), was designed as an alternative to using beeswax, or bone wax, to control bleeding during surgery.

At the start of heart surgery for coronary artery bypass grafts (CABG) or heart valve replacement, cardiac surgeons have to cut the patient’s sternal bone, Wellisz said, and the bone morrow can pour out and bleed. For the past 100 years, he said, surgeons have been using beeswax to stop the bleeding, but that wax never goes away in the body, thus increasing the risk of infection and preventing the bone from healing.

Ostene, on the other hand, is an “effective bone hemostasis agent that does not inhibit osteogenesis and bone healing,” Wellisz said.

There have not been any clinical studies done using Ostene in humans, Wellisz acknowledged, but the company has received FDA 510(k) clearance.

The high-tech medical devices on display at the conference, like the above-mentioned Thermogard from Alsius and Datascope’s CS300, were definitely worth checking out.

The Thermogard, for instance — which attendees could feel for themselves was warm to the touch — is designed to keep patients warm during surgery.

Traditional ways of warming up a patient during a procedure include turning up the heat in the operating room or putting a special type of blanket over them, West Long, a sales manager for Alsius, told MDD. With the Thermogard, doctors insert the catheter directly into the patient’s vein to warm their blood as it passes by, he said.

Or, if the surgeon needs to induce hypothermia, the device can be used to cool the patient. It also acts as a central line.

“You don’t want people having to generate heat while they’re going in for a cardiac procedure,” Long said.

The Thermogard also can be used to comply with guidelines from the American Heart Association (Dallas) that require patients to be cooled at 33-degrees for 24-hours following a heart attack, Long said.

“The company has been working with hypothermia for about five years, but this [device] is designed to maximize the warming capabilities,” Long said.

And the CS300 balloon pump, the second in a line of fully automatic pumps made by Datascope, combines fiber-optic speed with automatic in vivo calibration, according to the company. The result is faster time-to-therapy, faster signal acquisition, and faster adaptation to rate and rhythm changes, Datascope said.

Another benefit of the CS300, Nicolas Gikakis, global product director, told MDD, is that it does not require a pressure bag or flush bag so there is no need to manage a pressure line.

“It’s one less thing for the nurse or doctor to have to worry about,” Gikakis said.