LAGUNA NIGUEL — Every year, 5 million women in the United States spend $2 billion in attempts to become pregnant. Consequently, many undergo unnecessary surgery.
But a new non-surgical device developed by Imagyn Medical Inc. in Laguna Niguel may revolutionize the way women are treated for infertility.
It's called the Fallopian Visualization System, and it enables doctors for the first time to look inside the fallopian tubes, the canal where eggs pass from the ovaries to the uterus.
The visualization system consists of a long, thin catheter system and a 0.5-millimeter fiber-optic camera lens, called a Falloposcope, that transmits images back to a television camera and monitor. With this system, physicians changed preliminary diagnoses of two-thirds of test patients.
Having spent four years and $12 million perfecting the fallopian visualization system, Imagyn executives are now selling it in 17 countries for roughly $25,000 plus an additional $350 per disposable catheter.
The company anticipates initial domestic sales of $131 million once the product is marketed to this country's 1,800 infertility specialists for an estimated 320,000 annual procedures. Company officials said they expect approval by the U.S. Food and Drug Administration for U.S. sales early next year.
Imagyn, which began with a $22.6-million investment, is expected to break even in 1995 and may become a publicly held company within 18 months to raise more capital for its next stages of development.
"I don't know if the FVS will improve greatly upon the success rate of pregnancies. But it will provide a more cost-effective and accurate diagnosis that's less invasive than the current surgical procedures," says Glendon French, chairman and chief executive officer. "We're actually able to see what could potentially be causing the infertility. Before, we could only guess."
That guesswork has involved a battery of hormonal, surgical and other techniques to aid reproduction that can take one to five years and cost between $10,000 and $80,000. Blocked or damaged tubes account for nearly half of all female infertility problems, which affect a quarter of all women in the United States between 35 and 44, French said.
Current techniques cannot detect internal tubal disease or damage--which are 25% inaccurate in detecting blockage--and often require surgery. One involves injecting dyes into the uterus and viewing blockages through X-rays, which are potentially damaging to eggs. Another involves viewing the fallopian tube exterior through a tubular camera inserted through the stomach and into the abdominal cavity, which requires general anesthesia.
In contrast, the Imagyn visualization system catheter is passed through the vagina and into the uterus, where a balloon-like membrane containing a fiber-optic scope further extends through the fallopian tube. The less-costly procedure reduces recovery time, because it requires only local anesthesia or light sedation.
"I think it could be a major breakthrough for the infertility search, because it gives us a whole new approach and access to an area we could never get to before," says Eric Surrey, the acting director of the division of reproductive surgery at Cedars Sinai Medical Center in Los Angeles, one of six medical centers nationwide that ran clinical trials. UCI Medical Center in Orange will be involved in future studies of the system's therapeutic applications.
During the earlier studies, which were conducted during an 18-month period that ended last year, the system had an 86% success rate for accessing the tubes and, once they were accessed, a 94% success rate in providing an effective view of the tube interior.
"During our trials, two of our patients had debris (in the tubes) that we were able to remove with the FVS through gentle irrigation," said Surrey. "Without it, our only other alternative would have been to proceed blindly through major surgery or in-vitro fertilization."
Such procedures, which cost up to $30,000 and are not covered by all insurance programs, require a five-day hospital stay, with a two- to three-week recovery time, Surrey said. The Imagyn procedure could be done during an office visit and costs around $2,000.
The fallopian visualization system actually sprang from a decade-old prototype to unclog blood vessels. It was invented by Thomas Fogarty, a vascular surgeon based at Sequoia Hospital in Redwood City near San Francisco, who licensed it to Baxter Healthcare Corp. in Irvine. Baxter then licensed the technology to Imagyn, which was founded in 1989 by Guy Lowery, Keith Tholin, Steve Bacich and Fogarty to develop the product for gynecological use.