In short
Seattle-based Mirador Biomedical states on its homepage that by using its simple disposable pressure transducer practitioners can concentrate on what’s important: their hands, the patient, and the procedure. The company has coined the phrase “Point-of-Use Pressure” to describe its Compass™ simple in-line transducer, which means no waiting, no cables, no calibration, no external monitors, no saline columns, no more manometers.
Background
When you think about it, being able to measure pressure in an operative or perioperative setting is in many procedures the main protection the operator has against inadvertent puncture of the wrong target, or at very least confirmation that the correct organ or vessel or void has been found. Mirador Biomedical’s simple disposable device comes in a few iterations and is a simple and small in-line tool with an inbuilt pressure transducer. It is CE mark approved (and yes, even FDA approved) and available for the following indications:
Vascular Access
Compartment Syndrome diagnosis
Paracentesis
Lumbar Puncture
Epidurals
An interesting article on Orthopreneur, written by the developer of the technology, details its advantages in diagnosis of compartment syndrome, an oft-missed condition with potentially devastating consequences of muscle damage for the sufferer which can be completely avoided if diagnosed and treated early. The article demonstrates that while diagnostic tools may well be available, they usually involve locating pieces of capital equipment, with inherent delay. The author also suggests that; “missed or delayed diagnosis of compartment syndrome is one of the most common causes of litigation in orthopaedics.”
Compass ™ Electronic Pressure Transducer Platform
In contrast to current commercially available compartment pressure monitoring equipment, the Compass™ Electronic Pressure Transducer Platform, about the size of a golf ball, is lightweight, extremely portable and compatible with any standard needle (simple or side port), slit catheter and syringe. Unlike current systems that contain both an expensive capital piece and a pricey disposable component, the Compass is inexpensive and completely disposable, so it can be easily stocked in multiple hospital locations (e.g., in the OR supply room, on the floor, in the clinic, etc.), obviating the need to track down capital components in scarce supply.
The product received CE mark approval last July and FDA approval in December.
Status in Europe
Whether the device enters the European market with a degree of gusto depends very much on the clinical economics of the exercise. Despite company claims that it is inexpensive, we’ve no idea what that means, nor the extent to which the costs of avoidable mishaps and delayed diagnoses currently have a value placed on them. If problems associated with inadvertent arterial puncture when inserting central lines or catheters have a cash amount attached to them, presumably Mirador will find plenty of open doors.
Source: Mirador Biomedical, Orthopreneur
published: February 15, 2012 in: Approval/Clearance, Economics, Launches / Withdrawals, Regulatory, Technology