This is a story about making heart valves in Orange County,and it isn’t about Edwards Lifesciences Corp.
A short distance from Edwards’ Irvine headquarters, rival Medtronic Inc. has some 500 people making heart valves from pig tissue in a Santa Ana plant on Deere Avenue.
The Medtronic Heart Valves unit has its origins in OC’s venerable medical device industry. The operation grew out of Hancock Laboratories, started by engineer and valve pioneer Warren Hancock in 1969.
Hancock, like many of OC’s other seminal device figures, emerged out of the original Edwards started by Santa Ana electrical engineer Miles “Lowell” Edwards.
Besides Hancock, several other engineers who worked at Edwards went on to start their own device companies, including Donald Shiley, founder of Shiley Laboratories, and the late James Bentley, who started Bentley Laboratories.
Johnson & Johnson bought Hancock Laboratories in 1979. In the mid-1980s, Medtronic picked up the Hancock valve portfolio from J & J.;
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Campbell, McNatt: “One of the big challenges is that we’re buying pig parts and want to make them into devices for people,” Campbell says |
“There’s a rich history of our device in Orange County,” said John Mack, Medtronic’s corporate senior director of marketing. “We’ve invested heavily, and we are aggressive.”
Minneapolis-based Medtronic, which had $10 billion in sales for the 12 months through March, is a broad medical device company with a recent market value of $65 billion.
Besides heart valves, Medtronic makes cardiac rhythm management, spinal, ears, nose and throat devices as well as surgical navigation products and treatments for vascular disease.
Medtronic is the No. 3 player in heart valves, behind Edwards and St. Jude Medical Inc., also based in Minneapolis. Medtronic’s valve sales were $65 million in the quarter ended April 29.
Edwards had valve sales of $117 million in the first quarter. St. Jude’s valve sales were $67 million in the period.
“We’ve made enormous strides in our market share for the last five to seven years,” Mack said.
Medtronic’s been in its current Santa Ana spot for more than seven years, said Tom McNatt, the plant’s site leader in charge of manufacturing.
The third-generation Mosaic and Freestyle valves, along with the second-generation Hancock II, are made there.
Medtronic Heart Valves also makes repair products, such as annuloplasty rings, at the Santa Ana plant. The ring is inserted around the mitral valve to make sure it doesn’t stretch out again after surgery, said Andy Campbell, senior director of research and development.
Like Edwards, Medtronic is getting into percutaneous, or less-invasive, heart valves, which many see as the future of the industry. The valve’s research was done in Santa Ana.
Medtronic is planning to start an initial Food and Drug Administration clinical trial for its less-invasive valve, which has the working title of Medtronic Melody. The trial is expected to start within the next 12 months, according to Campbell.
Medtronic is working with Phillip Bonhoeffer, an English heart surgeon who in the past four years has implanted 83 of the valves in children, teens and young adults with defective valves.
Medtronic’s core valve operation in Santa Ana starts with what are called “aortic roots” from pigs. Edwards makes valves from both cow and pig tissue.
Making valves is a sophisticated operation involving clean rooms and precise production by hand. But the raw materials side is more Farmer John than FDA.
“We’re driven by the schedule of slaughterhouses to a large extent on the front end of the factory,” Campbell said.
Medtronic gets ice chests with pig tissue that come in “literally seven days a week, 24 hours a day,” Campbell said.
Preparing the tissue involves dissection and chemical treatment, along with sterilization and “bioburden reduction,” which removes any traces of bacteria.
“One of the big challenges is that we’re buying pig parts and want to make them into devices for people,” Campbell said. “We’ve got to make sure (a valve) is sterile when it leaves here.”
Finding research scientists to work in OC hasn’t been difficult, Campbell said. It’s been more challenging to find production engineers and those workers who get research into production, he said.
Medtronic has about 20 people working in research and development in Santa Ana. The R & D; unit came up with a process to decrease the rate of degradation of tissue valves, Campbell said.
“The main thing we try and do is make devices last long, and we try and make them so they can be implanted more easily and quickly by the surgeon,” he said.
Tissue heart valves, on average, last some 15 years, up from five to seven years for the earlier tissue valves, Campbell said. Tissue valves typically are implanted in people 65 and older.
Medtronic makes mechanical valves out of Minneapolis.
Mechanical valves generally are used in patients under 65 years of age because they last longer than tissue valves. But mechanical valves have lost some favor because patients who have them are required to take anticoagulant drugs, which can cause bleeding problems and also have been linked to birth defects.
