Medical Device Daily Associate

NovoSci (The Woodlands, Texas), an emerging medical technology company, reported that the Washington DC VA Medical Center (DCVAMC) is the first VA center and regional Washington cardiac surgery center to be actively using its new miniaturized bypass technology, the Ready System 200, on all types of cardiac surgery procedures, performing more than a dozen cases in the past two months.

The Ready System 200 was cleared by the FDA for marketing in the U.S. last year. The company said that bypass procedures totaled roughly 450,000 in 2001 in the U.S., and nearly 85% of those required placing the patient on a heart-lung machine — i.e., cardiopulmonary bypass or CPB — to circulate blood through the body while the heart and lungs are stopped.

The main components of the half-century-old conventional heart-lung bypass machine are numerous, but primarily include a mechanical pump, oxygenator, large cannula and substantial PVC tubing. The total machine often is referred to as simply “the pump.'

“To repair most cardiac defects, a cardiothoracic surgeon needs a bloodless and motionless field in which to operate — so the heart and lungs must be stopped,“ said Michael Sorna, president and CEO of NovoSci. “For this to happen, there must still be a way for blood to circulate throughout the body to deliver the nutrients and oxygen necessary for life.“

In the past, he said, “this has been made possible via technology invented in 1953 known as cardiopulmonary bypass, or CPB — which permits a patient's blood to bypass his heart and lungs, thus achieving the desired 'bloodless and motionless' operative field, while still supplying all the other organs with a constant supply of oxygen and nutrient-rich blood.“

Sorna added: “While 'the pump' has been a lifesaver, literally, to many, this classic technology is well-known to cause deleterious side effects: For example, the conventional heart-lung machine typically draws large volumes of blood from the patient and places it in a hard-shell venous reservoir, where it is exposed to air, silicone and a large foreign surface.“

Gregory Trachiotis, MD, associate chief of the division of cardiothoracic surgery at DCVAMC, said, “The conventional pump can be very stressful for some patients, making survival much more challenging for the sickest.“

He said the mini-pump “has big advantages over traditional cardiopulmonary bypass. For example, because it's much smaller, blood flows over far less foreign surface, an aspect of conventional bypass that can be associated with life-threatening physiological or neurological complications.“

There are several other important advantages, Trachiotis said, “which is why we are using the Ready System here at DCVAMC. I believe it is likely that the mini-pump will replace the conventional form of CPB as the 'gold standard' for most cardiac procedures over time.“

Sorna told Medical Device Daily that NovoSci emerged out of open-heart surgery medical technology supplier Jostra AG's (Hirrligen, Germany) Jostra-Bentley division in the U.S. Sorna said he decided to restructure the company, which became private and changed its name to NovoSci after Jostra was sold to Getinge (Getinge, Sweden) in 2003, when he came on board. That included exiting the custom surgical tubing market that the company was involved in.

When he realized that NovoSci could not make any money in that business, primarily due to competition from much larger competitors, Sorna issued a directive to find a use for the patents acquired via the Bentley and Lifestream International (also The Woodlands) buys. His team came back to him saying that the Achilles' heel of the cardiovascular community “truly is the deleterious side effects of cardiopulmonary bypass circuits.“

What the company was looking for, he said, “was a product that essentially could either significantly reduce or eliminate the need for blood products and transfusions, and then the other [problem] being the inflammatory side effects by cardiopulmonary [bypass]. We feel that this is the future of perfusion.“

The single-use mini systems, which cost roughly $1,100 to $1,200 each, come complete in a box and can be quickly assembled and easily attached to a pole and be up and running in two to five minutes. Perhaps a more important aspect, Sorna noted, is the pump's 650 cc priming volume, which is about one-third of the average for the traditional CPB system. This lower priming volume, he said, leads to decreased hemodilution and decreased blood transfusion.

Another important aspect of the system is that the company was able to get away from the use of a hard-shell reservoir, used in other CPB systems. This allowed NovoSci to apply a vacuum within the venous reservoir, greatly reducing the exposure of blood in the system to air within the system.

“The important aspect of this,“ Sorna said, “is that the perfusionist could run the system exactly the same way as they do with large circuits with hard-shell reservoirs.“ He also noted that the system is the only miniaturized device on the marketplace without a hard-shell reservoir that can run vaccum-, gravity- or kinetic-assisted venous return, the three modes that perfusionists run.

While the company is very bullish on the system, Sorna acknowledged that NovoSci would have to sell traditionally conservative thoracic surgeons on the technology. “It's really a pioneering mode. It's really having to go in and convince the surgeon and the perfusionist that their turf and their patient benefit needs to be protected.“

To bolster use of the system, the company is striving to give its potential customers hard data on the benefits of the new technology via the 500-patient RESULT registry trial.

Sorna said he believes NovoSci will be successful “[If] we can give [surgeons] the data showing that the deleterious side effects of cardiopulmonary bypass can essentially be significantly reduced or alleviated with systems of this type.“

Currently, traditional CPB kits fetch a price of around $600, and Sorna acknowledged that the Ready System 200's premium cost could initially be a significant hurdle to adoption. He said that the company hopes to bolster its case for a higher price by showing, via secondary endpoints in the RESULT registry, a significant reduction in or no use of blood products, and from what he has seen in side studies done in Europe on the product, he is confident that these outcomes will be achieved.

“We know it's going to show a reduction in the use of blood products, we know it's going to show a reduction in ICU time and we know it's going to probably show a reduction or elimination of the need to put people on a ventilator.“

Sorna said that the DCVMA, the company's first registry hospital and training center, already has performed 15 cases with the system.

Milestones that NovoSci has set for this year include the establishment of 10 centers of excellence for use of the Ready System that will also be enrolled in the RESULT registry, as well as the successful completion of that registry.

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