A cardiologist at the University of Virginia Health System hopes a device he invented could improve outcomes for heart surgery patients — and make it easier to do his job.
Dr. Scott Lim, an associate professor of pediatrics and medicine, co-founded 510 Kardiac Devices with Jaime Sarabia, an entrepreneur and engineer based in Atlanta. The early-stage company is developing a device to aid cardiologists in operations on the left side of the heart.
The left side of the heart receives oxygenated blood from the lungs and pumps it out through the aorta, the body’s main artery. To minimize risk of arterial bleeding, cardiologists typically access the heart’s left side by running a catheter through veins into the right side of the heart and puncturing the septum, a membrane that separates the left and right atria.
Sarabia said that only about 10 percent of interventional cardiologists in the United States are proficient at transseptal punctures.
“It is a dangerous and difficult step, and the technology behind it hasn’t evolved in 60 years,” Sarabia said. “We could make it safer, better and more efficient.”
The Lim Transseptal System is designed to give surgeons more precise control of the catheter when targeting specific locations within the heart after a transseptal puncture. It also promotes maximum visibility in an echocardiogram.
“We are reshaping catheters so they can take curves and cross from one side of the heart to the other,” Lim said.
“Rather than accepting what anatomy gives to you, you can drive the catheter to specific locations,” Sarabia said. “It gives surgeons a much better starting point.”
Early in his career, Sarabia was part of a small team of engineers at Evalve that designed the MitraClip heart implant. Evalve was acquired by Abbott for $410 million in 2009.
Sarabia met Lim through his work as a market development manager for Abbott.
“Dr. Lim was one of the most influential interventional cardiologists in the launch of [mitral valve therapy],” Sarabia said. “He has used this technology with high clinical success, and has trained dozens of physicians around the world.”
510 Kardiac gets its name from the Food and Drug Administration’s 510(k) clearance. The 510(k) streamlines the regulatory process by allowing a manufacturer to demonstrate that its device is substantially equivalent to another device already on the market that did not require premarket approval.
Sarabia said it took more than a decade to bring the MitraClip to surgeons and patients He said he is excited by 510 Kardiac’s focus on smaller innovations that could still have substantial impact.
“We want to be smart about technologies we choose to pursue, and develop technologies that we can bring to market more quickly,” he said.
510 Kardiac has manufactured several prototypes of the Lim Transseptal System, and has tested them on animals and human cadavers. Lim said the device is on track for FDA approval by the end of 2018.
510 Kardiac Devices recently received the UVa Licensing & Ventures Group Seed Fund’s fourth investment, joining TypeZero Technologies, TearSolutions and Mission Secure. Individual investment amounts were not disclosed.
UVa created the $10 million seed fund in 2016 with funding from the university and its Health System to support new ventures emerging from the university’s intellectual property portfolio.
“We are getting more and more applications from across Grounds and the hospital,” said Bob Creeden, managing director of the seed fund.
Creeden said 510 Kardiac’s co-founders inspire confidence in investors with their impressive professional experience and ability to work together as a team.
Nextern Medical, a Minnesota-based medical design and manufacturing firm, joined the Licensing & Ventures Group in 510 Kardiac’s latest round of investment.
“Nextern Medical has 25 years of experience with developing devices for the cardiac space, so their investment is real validation for 510 Kardiac,” Creeden said.
“Any new technology, even if it’s fascinating and great, takes money to bring it to market,” Lim said. “But the Licensing & Ventures Group has also been quite generous with their time and their advice. It’s a tremendous partnership for us.”