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products are sold separately, and many are sold in custom kits consisting primarily
of selected combinations of products. We have not
experienced any significant product liability claims; however, the sale and use
of our products entail inherent risks that customers may assert product liability
claims against us. We maintain product liability insurance in the amount of $10,000,000
per occurrence and $10,000,000 in the aggregate, which may not be adequate to
cover potential expenses or liabilities we could incur if we face a products liability
claim. We also maintain product liability insurance for events in the United Kingdom
in the amount of 5,000,000 GBP (Great Britain Pounds) per occurrence and in the
aggregate, which also may not be enough to cover our actual expenses or liabilities.
The following paragraphs briefly describe and provide
other information regarding our products: Inflation
Devices and Angioplasty Accessories. Angioplasty is a procedure used to
clear blockages in arteries by inserting and inflating a small balloon in the
clogged arteries. Our inflation devices are large, specialized syringes used to
inflate balloon-tipped catheters in angioplasty procedures. Our inflation devices
incorporate patented, proprietary design features which contribute to their ease
of use, including features that allow clinicians to engage or release the syringe
plunger with one hand. Each syringe also provides a clear view of the fluid path;
this makes it easier for the user to debubble and to accurately measure the pressure
in the syringe. Our IntelliSystem® inflation device,
which was the first such device to incorporate electronic sensing and display
features, is a disposable 20cc inflation syringe with an internal pressure transducer
which connects to a monitor outside of the sterile field. The IntelliSystem® monitor
measures, times, records, and digitally displays information concerning the pressure,
duration and number of each inflation and deflation of the angioplasty balloon.
We believe that electronic sensing and display of such information is more accurate
and precise than most conventional analog gauges. By using electronic sensors,
important data can be stored and later retrieved, displayed and printed. In
2003, we launched the patented IntelliSystem II™ color monitor, an advanced balloon
inflation system. It gives physicians several desirable options, including a large
color touch screen, an instant readout of positive and negative pressures, and
an enlarged graphing display to show subtle changes in pressure measurements.
In addition, the readouts are available in four languages. The user can change
settings and programming by simply touching the screen. Management believes that
Merit is the only company with digital technology sensitive enough to show subtle
changes in pressure. The Monarch® is a disposable
inflation device that digitally displays data concerning pressure and duration
of inflations and deflations on a small digital readout mounted on the barrel
of the inflation syringe. This small digital readout monitor does not offer the
same display, storage or printing capabilities of the IntelliSystem® & IntelliSystem
II™, but does offer the convenience of portable, digital operation. In 2003, we
launched a 30-atmosphere version of the Monarch® to provide clinicians with additional
options. The Viceroy™, Basix® and the BasixCOMPAK™
are disposable inflation syringes that incorporate conventional analog pressure
gauges mounted on the barrels of inflation syringes. The Basix® resembles devices
marketed by our competitors, but includes our proprietary design features and
benefits. We believe the Basix® and BasixCOMPAK™ represent significant additions
to our line of inflation devices, and will contribute to increased sales where
both clinical outcomes and pricing are priorities. Hemostasis
Valves. Hemostasis refers to the stoppage
of bleeding in an injured blood vessel. We sell a line of hemostasis valves designed
to complement our inflation devices. These valves are also sold as a part of our
angioplasty product packages. This line of valves includes the MBA™, Passage®,
AccessPlus™, Access 9™, and Double Play™, hemostasis valves. These valves are
made of clear polycarbonate plastic for strength and clarity; however, the devices
vary in size and function. The MBA™ features a valve mechanism that minimizes
blood loss during exchange of wires, catheters and other tools through the valve.
The Access Plus™ and Access 9™ are large-bore configurations. The Double Play™
incorporates a double “Y” configuration for kissing-balloon techniques. | |
