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FDA delays approval of South Side-made artificial Hemolung

| Wednesday, July 2, 2014, 11:26 p.m.
Stephanie Strasburg | Tribune-Review
Jon Sacker, 33, of Moore, OK and his wife Sallie Sacker, 32, pose for a portrait in Jon's hospital room at UPMC Presbyterian in Oakland on Wednesday, July 2, 2014. Jon came to Pittsburgh for his second double-lung transplant after battling cystic fibrosis and rejecting his first set of transplanted lungs. He was the first US patient placed on the Hemolung RAS, a device never before used in the US.
Stephanie Strasburg | Tribune-Review
ALung Chairman and CEO Pete DeComo holds an example of Hemolung RAS, an artificial lung used outside of the body, as he talks in a press conference with William Federspiel, PhD (center) and Christian Bermudez, MD (right) at UPMC Presbyterian in Oakland on Wednesday, July 2, 2014. Jon Sacker, 33, of Moore, OK, came to Pittsburgh for a double lung transplant and was the first US patient placed on the Hemolung RAS, a device never before used in the US. DeComo himself drove to Canada to pick up a lung for Sacker's transplant when one became available in the middle of the night.

An artificial lung made in the South Side could help save nearly 1 million people a year, with the innovation having treated about 200 critical patients around the world, its makers say.

Now they have a stateside success story that doctors are calling a near-miracle.

UPMC Presbyterian patient Jon Sacker, 33, of Moore, Okla., became the first person in the United States fitted with the Hemolung Respiratory Assist System, hospital officials announced on Wednesday. They said the system filtered carbon dioxide from Sacker's body for 20 days, stabilizing his health and letting him live long enough that doctors could perform an essential lung transplant in March.

“Today I'm doing really well,” Sacker said, his voice raspy but clear as his recovery continues in the Oakland hospital. “There's no doubt: If we had not had that machine, I probably wouldn't be here. It's that good.”

South Side-based ALung Technologies Inc. started developing the Hemolung, in effect an artificial lung, about 11 years ago. It's similar to traditional extracorporeal membrane oxygenation, or ECMO, an established technology that performs lung functions outside the body.

But for Sacker, who has cystic fibrosis, and thousands of other fragile respiratory patients, ECMO can be too physically traumatic.

Hemolung offers a simpler, less invasive approach that concentrates on removing carbon dioxide from the blood in the short term, said ALung CEO Pete DeComo. It features a mechanized spinning core in a transparent cylinder about the size of a small mixing bowl. A small catheter connects the cylinder to the body.

The technology won regulatory approval during the past year or so in 29 countries, including Canada, but it remains under Food and Drug Administration review.

An FDA spokeswoman said the agency would not discuss a device that's under consideration. ALung executives said the review process for widespread use in the United States could take three to five years.

“Suffice it to say the FDA has the most complex and challenging process for approval of all the countries,” DeComo said.

He drove through the night to Toronto to fetch a Hemolung for Sacker, who was very ill when his UPMC doctors won an emergency exemption from federal and local regulators to use the unapproved technology in February.

Sacker and his wife, Sallie, 32, came to Pittsburgh as a last resort after his body rejected the transplanted lungs he received two years ago.

“To be honest with you, we didn't have a lot of hope in the beginning when we saw him the first time,” said Dr. Christian Bermudez, chief of cardiothoracic transplantation at UPMC. He called it “almost a miracle” that doctors kept Sacker alive with the Hemolung.

A complete set-up for the device costs about $41,000, including about $35,000 for a machine that operates the artificial lung component. That machine is reusable, and each patient receives a separate artificial lung, catheter and associated pieces. Those together run about $6,000.

Countries from Europe to the Middle East and Latin America have approved the Hemolung, with more signing off on the device every month, according to ALung. The company took shape in 1997 as a spinoff from the University of Pittsburgh and now employs 45 people, 35 of them at its headquarters on Jane Street.

Ten are alumni of Pitt's bioengineering program, said William J. Federspiel, an ALung co-founder who helped develop the Hemolung. The company estimates a potential global market for the product worth about $6 billion a year, focusing especially on patients with acute respiratory distress symptoms and chronic obstructive pulmonary disease.

About half of the projected market for Hemolung would be in the United States, said ALung Vice President Scott Morley.

For Jon Sacker, the equipment worked almost instantly, his wife said. He hopes to return home to Oklahoma within several weeks.

“We've been married 10 years, and we dated for six years before that,” Sallie Sacker said. “Knowing he was going to make it was probably the pinnacle of my life, because I don't want ever to let him go. I wasn't ready for that.”

Adam Smeltz is a staff writer for Trib Total Media. He can be reached at 412-380-5676 or asmeltz@tribweb.com.

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