November 14, 2024

Novelties: The Artificial Heart Is Getting a Bovine Boost

Now Carmat, a company based in Paris, has designed an artificial heart fashioned in part from cow tissue. The device, soon to be tested in patients with heart failure, is regulated by sensors, software and microelectronics. And its power will come from two external, wearable lithium-ion batteries.

Fifteen years in development, the heart has been approved for clinical trials at cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia, where staff members are receiving training and patients are being screened, said Dr. Piet Jansen, medical director at Carmat.

In France, where the device is not yet cleared for human implantation, regulators have requested more animal tests, Dr. Jansen said; those tests are continuing.

Artificial hearts aren’t new, of course, but the Carmat heart is unusual in its design, said Dr. Joseph Rogers, an associate professor at Duke University and medical director of its cardiac transplant and mechanical circulatory support program. Surfaces in the new heart that touch human blood are made from cow tissue instead of artificial materials like plastic that can cause problems like clotting.

“The way they’ve incorporated biological surfaces for any place that contacts blood is a really nice advantage,” Dr. Rogers said. “If they have this design right, this could be a game changer.” He added that it could lessen the need for anticoagulation medicines. (Dr. Rogers has no financial connections to Carmat.)

This is the first artificial heart to use cow-derived materials — specifically, tissue from the pericardial sac that surrounds the heart. Biological tissue has been used in earlier mechanical blood pumps only in valves, Dr. Rogers said.

Thousands of people in the United States need a replacement heart, said Dr. Lynne Warner Stevenson, a professor at Harvard Medical School and director of the cardiomyopathy and heart-failure program at Brigham and Women’s Hospital in Boston. “It’s estimated that if we had enough donor hearts to go around, 100,000 to 150,000 people in the United States with heart failure would benefit,” she said. “Transplants work best, but we have only 2,000 or so adult hearts” that are available each year, she said. “It’s a huge problem.”

There are long-established options for patients while they await transplants, Dr. Stevenson said, including installing an artificial heart made by SynCardia until a donor heart is available.

When the natural heart is partly damaged or diseased, patients might keep it and have a mechanical aid implanted to bolster blood flow. Such pumps — especially those that aid the left side of the heart — are in wide use both as a bridge to a transplant and for lifetime therapy.

A totally artificial heart for extended use would be of great value, but it’s far too early to know if the Carmat heart, as yet untried in humans, will be that device. “The whole history of mechanical devices is that people thought they had devices where blood wouldn’t clot. But they didn’t,” Dr. Stevenson said.

Dr. Jansen said that the cost of the Carmat heart would be about $200,000 and that he did not expect it to be brought to market in Europe before the end of 2014. Once the company gains momentum with its European clinical studies, he said, it plans to start working through the regulatory process in the United States.

The Carmat heart has two chambers, each divided by a membrane. That membrane has cow tissue on one side — the side that is in contact with blood — and polyurethane on the other side, which touches the miniaturized pumping system of motors and hydraulic fluids that changes the membrane’s shape. (The motion of the membrane pushes the blood out to the body.) The embedded electronics and software adjust the rate of blood flow. Patients can wear the batteries under the arm in a holster, or in a belt, among other options.

Cow tissue is also used for the heart’s artificial valves, which were created by Dr. Alain Carpentier, a cardiac surgeon and a pioneer of heart valve repair who is also a co-founder of Carmat and its scientific director. Such valves have been used in heart-valve replacement surgery for decades. The cow tissue is chemically treated so that it is sterile and biologically inert.

The heart’s design and development relied heavily on aerospace testing strategies by EADS, the European Aeronautic Defense and Space Company, one of Carmat’s backers, Dr. Jansen said. Even so, duplicating the durability of a human heart will not be easy, said Dr. Robert Kormos, director of the artificial heart program at the University of Pittsburgh Medical Center and co-director of its heart transplant program.

“We can test these pumps on the bench in the laboratory, and in animals, but there is no true long-term data until you implant them in people for trials,” he said.

DR. JANSEN said that one design requirement for the heart was that it last five years. The company has been doing bench tests to see whether the new heart will stand up to that level of wear and tear. “Whether it lasts five years in the patient we will have to prove clinically,” he said.

Dr. Stevenson of Harvard is optimistic about the new device.

“Innovation is what we need,” she said. “This new device is exciting. I applaud the pioneers who developed it, and the patients and families who will go down this path for the first time.”

E-mail: novelties@nytimes.com.

Article source: http://www.nytimes.com/2013/07/14/business/the-artificial-heart-is-getting-a-bovine-boost.html?partner=rss&emc=rss

Norman Krim, Who Championed the Transistor, Dies at 98

The cause was congestive heart failure, his son Robert said.

Mr. Krim, who made several breakthroughs in a long career with the Raytheon Company and who had an early hand in the growth of the RadioShack chain, did not invent the transistor. (Three scientists did, in 1947, at Bell Laboratories.)

But he saw the device’s potential and persuaded his company to begin manufacturing it on a mass scale, particularly for use in miniaturized hearing aids that he had designed. Like the old tube, a transistor is a semiconductor that amplifies audio signals.

As Time magazine wrote in 1953: “This little device, a single speck of germanium, is smaller than a paper clip and works perfectly at one-tenth the power needed by the smallest vacuum tube. Today, much of Raytheon’s transistor output goes to America’s hearing aid industry.” (Germanium, a relatively rare metal, was the predecessor to silicon in transistors.)

That was just the start. “Now there are over 50 million transistors on a single computer chip, and billions of transistors are manufactured every day,” Jack Ward, curator of the online Transistor Museum, said in an interview. “Norm was the first to recognize the potential and led Raytheon to be the first major transistor manufacturer.”

Thousands of hearing-disabled people benefited from Mr. Krim’s initial use of the transistor in compact hearing aids. But not every transistor Raytheon made was suitable for them, he found.

“When transistors were first being manufactured by Raytheon on a commercial scale, there was a batch called CK722s that were too noisy for use in hearing aids,” said Harry Goldstein, an editor at IEEE Spectrum, the magazine of the Institute of Electrical and Electronics Engineers.

So Mr. Krim contacted editors at magazines like Popular Science and Radio Electronics and began marketing the CK722s to hobbyists.

“The result was that a whole generation of aspiring engineers — kids, really, working in their garages and basements — got to make all kinds of electronic projects,” Mr. Goldstein said, among them transistor radios, guitar amplifiers, code oscillators, Geiger counters and metal detectors. “A lot of them went on to become engineers.”

Mr. Ward called Mr. Krim “the father of the CK722.”

Before the transistor, Mr. Krim had already made significant contributions to the industry. In 1938 he led a Raytheon team that developed miniaturized vacuum tubes for use in battery-powered radios. He also realized that the small tubes could replace cumbersome packs that hearing-aid users had to strap onto themselves in those days.

“Zenith, Beltone, Sonotone are some of the American companies that used his improved, more affordable hearing-aid technology,” said Chet Michalak, who is writing a biography of Mr. Krim. “His devices were about the size of today’s hand-held phones.” They were also a precursor to the transistor hearing aid his team later developed.

Norman Bernard Krim was born in Manhattan on June 3, 1913, one of four children of Abraham and Ida Krim. His father owned several luncheonettes. By the age of 12, he was tinkering with the refrigerator motor in his home.

After graduating from George Washington High School at 16, he was accepted at the Massachusetts Institute of Technology, where in his junior year he built an “electrical brain” that, according to newspaper articles at the time, seemed to be able to make childlike choices, deciding whether it preferred beets or spinach, for example.

“He considered it a carnival act,” Mr. Michalak said.

Raytheon hired Mr. Krim after his graduation in 1934, at 50 cents an hour. By the time he left the company in 1961, he was vice president of the semiconductor divisions.

Mr. Krim’s wife of 52 years, the former Beatrice Barron, died in 1994. Beside his son Robert, he is survived by another son, Arthur, and four grandchildren. Another son, Donald, a leading film distributor, died in May.

After leaving Raytheon, Mr. Krim bought two electronics stores in Boston called RadioShack. By the time he sold the business to the Tandy Corporation two years later, it had seven stores; today the chain has about 7,300.

Mr. Krim was a marketing consultant to Raytheon and several other companies until 1997.

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