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July 27, 2004 – Verimetra Inc. and a Pittsburgh-based team of medical and robotic researchers have begun testing what could lead to groundbreaking fetal surgeries.
The group met in June at Children’s Hospital of Pittsburgh to begin animal tests with a sensor-enabled surgical tool that one day could repair a defective fetus heart while measuring the blood flow and providing other tactile feedback to surgeons.
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Verimetra has embedded a microsensor and a series of bar codes on the tip of a catheter used in balloon angioplasties before inserting it into a rat, whose heart is similar in size to that of a 20- to 24-week-old fetus.
Early results have shown that the catheter can be visualized and the MEMS-based sensor can track blood flow changes as the catheter progresses through the heart’s vessels.
“We were very pleased,” said Dr. Bradley Keller, the hospital’s chief of pediatric cardiology. “There’s still significant work we need to do to translate this experiment into a clinical catheter we can use in patients, but we’re certainly moving in the right direction.”
Although the research team had been working for more than a year, still in need of seed money to move into prototype development and testing. The researchers learned in early 2004 that it would get $100,000 from the Pittsburgh Life Sciences Greenhouse.
The money follows a $58,000 grant last fall from Pittsburgh-based PNC Trust to the Children’s Hospital Foundation for its cardiac intervention program. In addition, the team received another earlier grant for developing software to image fetal hearts using robotics.
The Greenhouse funds, shared by Verimetra, Children’s Hospital and Carnegie Mellon University’s Medical Robotics Technology Center, specifically calls for developing sensors and guidance technologies embedded on tiny catheters to treat obstructions in the fetal heart’s left ventricle.
That’s important, according to team members, because such an obstruction can eventually lead to hypoplastic heart syndrome, a condition where the heart’s left side fails to grow properly and considered fatal 20 years ago.
According to the team’s research, infants born today with hypoplastic left heart syndrome require at least three surgeries. And that’s just to make it possible for the right ventricle to do all of the heart’s pumping and circulation work. Today, the chances of surviving into adulthood with the syndrome are less than 50 percent.
“Heart and blood vessels and valves require mechanical stress of blood flow to grow,” Keller said. “If you restore that flow, you can allow the heart to grow close to normally. It’s a critical window we’re trying to target.”
Cardiovascular experts say preserving both ventricles results in the best chance of long-term survival, which is why surgeons are investigating fetal surgeries. But such surgeries have been rare in part because of a lack of imaging technology.
Of course, sensors only fill part of the bill: Coming up with an integrated system has also required the expertise of Carnegie Mellon’s robotics center.
Jim Osborn, the center’s executive director, said last year that the complete system must collect all information from the sensors, as well as from other sources like the ultrasound used before and during operation. Then, the system must offer a meaningful and useful graphical display for the surgeon, who suffers from an inherent sensory deficit while operating within the fetus.
Beyond potential medical benefits, the project provides an opportunity to educate people on robotics.
“This is not what most people think of — it’s not what comes to mind when people think of robotics: factory robot arms that are painting and assembling, science fiction, R2D2, Commander Data,” Osborn said. “Those all have a very strong hardware connotation. A lot more of robotics is what you see underneath the hardware packages.”
Keller said the next step will be to perform a fetal trial on a larger animal, such as a pregnant ewe, so the team can test the catheter through an abdominal wall, uterus, and into the fetal heart. If all goes well, he said, the group could be moving into the first human trial in a year, and collaborating with other hospitals involved in fetal surgeries.
While the preliminary tests with smart sensors in fetal heart procedures are promising, Verimetra is moving ahead on several other fronts to demonstrate technology that literally sits at the cutting edge of surgical tools.
The company said it has performed animal trials with undisclosed but major medical device makers in the areas of cancer and heart disease. Michele Migliuolo, Verimetra’s president and chief executive, said the medical device makers paid Verimetra “to make catheters smart,” and arranged hospital trials.
He is particularly pleased with the recent progress treating heart-related ailments. “(We are) making progress in showing that MEMS flow sensors add value in the field of angioplasty, in particular, by providing real-time information, in this case about blood flow, to the doctor,” Migliuolo said.
“Flow sensors allow them to measure flow of blood at or near, for example, a constriction in a blood vessel before and after they perform a procedure to open up that constriction.”
Ultimately, Migliuolo seeks more than just surgical success. Verimetra is negotiating with two large device makers on future investments that could range from a distribution deal to outright acquisition.
“Large medical manufacturers, such as Boston Scientific, Johnson & Johnson and Medtronic, do not perform their own advanced research and development anymore. They acquire it after proving it,” he said. “With us it’s not a question of ‘does this technology work?’ We’ve proven it works… (Investment) is important because it proves the business model.”