Falloposcopy: The Future of Infertility Diagnosis?
Overview
The inability to access fallopian tubes easily and non-surgically greatly impairs accurate diagnosis of the tubes' health. The falloposcopy is a technology seeking a less invasive manner to create a more accurate diagnosis.
A falloposcope is a fallopian tube microendoscope. Used in conjunction with a hysteroscope, laparoscope or catheter based system, falloposcopes visualize the fallopian tubes to diagnose possible disorders.
Fallopian Tube Disorders
Causes for fallopian tube disorders, which induce 20-25 percent of infertility cases, include proximal and distal tubal blockage, which can be caused by infection, inflammation or endometriosis. Other causes include scar tissue and adhesions. All in all, any distortion or constriction of tube can prevent an egg and sperm from meeting.
Because fallopian tubes are very delicate, narrow, tortuous, and difficult to access, current non-surgical techniques for diagnosing fallopian tube diseases and disorders often do not adequately or accurately delineate the nature, extent and location of tubal pathology.
Diagnosis of Infertility
Most physicians rely on two tests to diagnose infertility: hysterosalpingography (HSG) and diagnostic laparoscopy.
According to some industry observers HSG is often painful and highly inaccurate, with false positive results in as many as 40 percent of HSG-diagnosed cases of proximal tubal occlusion (PTO). Lap and dye has a 20 to 40 percent rate of false positive diagnosis of proximal tubal occlusion.
Potential Patient Population
The potential patient population as well as procedure numbers for diagnosis and therapeutic options which falloposcopy could substitute for are shown in Figure 1.
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Figure 1 |
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| Potential Patient Population: | |
| Impaired fecundity | 6,100,000 women with impaired fecundity |
| Infertility | 5,000,000-8,000,000 couples: 1,400,000 sought treatment in 1988: Approximately 30% (490,000) attributable to fallopian tube disorder |
| Diagnostic Procedures: | |
| HSG | 600,000 performed annually |
| Lap & dye | 280,000 performed annually |
Market Drivers
The market drivers are all the trends, issues, economic factors, and measurement trends that are pushing the market to greater growth. Market drivers for the falloposcopy market include the following:
Market Restraints
The market restraints are the trends, issues, economic factors, and measurement trends that limit market growth. Market restraints are as follows:
Current Product Offerings
Current product offerings are as follows:
Imagyn
Imagyn's Ovation Falloposcopy System includes a flexible linear everting catheter, falloposcope, and irrigation pump. In 1997 the company received approval to distribute in the U.S.
Conceptus
Conceptus' STARRT System received FDA approval for indication of diagnosis of proximal tubal occlusion in January of 1997. The system includes the VS, Coaxess and Stargate catheters, Robust guidewire, Vision falloposcope, and Access hysteroscope. The Working channel of hysteroscope can accommodate Stargate catheter as well as other devices for tubal diagnosis, endometrial biopsy and therapeutic indications. Falloposcopy utilizing the catheter system allows for office based diagnostic procedures.
Karl Storz
Karl Storz currently sells a falloposcope in Europe which it plans to introduce to the U.S. market in the near future.
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