BIOSYSS CONTINUOUS NONINVASIVE BLOOD PRESSURE MONITOR 510(K)
This article was originally published in The Gray Sheet
Executive SummaryBIOSYSS CONTINUOUS NONINVASIVE BLOOD PRESSURE MONITOR 510(K) Biosyss' blood pressure monitor is based on proprietary "arterial pulse waveform analysis" technology. The system is comprised of a disposable piezoelectric sensor and an analyzer. The watch-sized sensor, which the firm says is "similar to... sensors found in geoseismic measuring devices," is applied at the wrist to measure the "pressure wave created in an artery as the heart pushes blood through the vessels," according to the company. The waveform information obtained from the sensor is then transmitted to a portable mechanical analyzer that uses "signal processing and proprietary algorithms" to translate the data into standard blood-pressure readings. The blood pressure readings, pulse values and a continuous arterial pulse waveform are displayed on a screen and updated every five seconds. Biosyss is aiming to launch the system in the hospital market in the second quarter of 1994. The firm plans to sell the system through distributors. Biosyss also is considering selling the device in the hemodialysis market. In June, the firm will begin a joint clinical study with Baxter to evaluate the monitor for use with hemodialysis patients. The study also will evaluate applying the Biosyss technology to the measurement of other diagnostic parameters important to dialysis procedures. Biosyss plans to sell the analyzer for about $5,000 and the disposable sensor component for between $6 and $7. When launched, Biosyss' system will compete with Nellcor's N-CAT, the only continuous noninvasive blood pressure system currently cleared for marketing. The Nellcor system, which is based on "arterial tonometry," is manufactured by Colin Electronics of Japan. Biosyss will position its system as having several advantages over conventional blood pressure measurement systems used in the hospital and dialysis markets. These technologies include invasive "A-line"-based systems and noninvasive noncontinuous automated blood pressure systems. The company notes that because A-line systems use a catheter, there can be problems with insertion and patient comfort, as well as a risk of infection. In addition, Biosyss says that although Biosyss and A-line hardware are similarly priced, A-line disposables are more expensive. The A-line disposable transducer and catheter set is priced in the $15-25 range. The Biosyss monitor's continuous measurement capability is the principal advantage over conventional automated blood pressure systems, which provide readings in three-minute intervals. Other advantages cited by the company include the elimination of the arm or finger cuffs, which can cause patient discomfort, edema and tissue damage. Farther back in Biosyss' pipeline is an ambulatory blood pressure monitor for the physician's office market. The company expects to file a 510(k) for the device by the summer of 1994, and anticipates a product launch by January 1995. The ambulatory blood pressure monitor system also uses arterial pulse waveform analysis technology. The monitor component, which is to be worn by the patient for a 24-48 hour period, is watch-sized and has storage and display capabilities. The information stored in the portable monitor is entered into a data retrieval station in the physician's office, which uses proprietary software to "print out a patient's 24-48 hour ambulatory blood pressure measurement and trends." The same station is used to program the monitor. The system, which includes the data station and three wrist units, will be sold for approximately $6,000. Biosyss also expects to use its core technology to develop systems that continuously will measure cardiac output, vessel compliance and cardiovascular fluid volume. The firm was co- founded in 1989 and has raised over $1.3 mil. in private funding. Co-founder and President Jeffrey Barnes previously held various management positions at Hewlett-Packard Medical Products. John Durbin, chief financial officer, has held management positions at Pfizer and Astra Pharmaceutical. Vice President of Sales and Marketing Michael Dawson was previously associated with Haemonetics and Bard.
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