FDA delays approval of South Side-made artificial Hemolung
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 email@example.com.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Steelers clinch playoff berth with win over Chiefs
- Starkey: Chryst a miserable failure at Pitt
- NYPD: Cop ambush killer told passers-by to watch
- Groom cited at Farmington wedding reception being filmed for reality TV show
- Outdoor notices: Dec. 22, 2014
- Ex-Penguins defenseman Niskanen still miffed by coaches’ firings
- Pitt football fights to overcome steppingstone status
- Car wash explosion, fire injures 2 in McDonald
- Pitt players support Rudolph for job
- Energy sector adjusts to global oil plummet
- South Fayette football team distributes Steelers tickets to Carlynton, Wilkinsburg