INDIANAPOLIS, Jan. 7 /PRNewswire/ -- Polymer Technology Systems, Inc. has
been granted conditional approval by the Food and Drug Administration approval
to begin investigational testing of its CFC (Capillary Filtrate Collector)
BioScanner System(TM). The conditional approval, based on the submission of
the investigational device exemptions (IDE #G990251) application, allows
Polymer Technology Systems, Inc. to begin testing subjects in accordance with
the FDA's investigational site waiver.
The CFC BioScanner System(TM) is an implantable device for testing of body
fluid collected subcutaneously. It is a combination of:
1. A device called the Capillary Filtrate Collector (CFC), which collects
body fluid subcutaneously and,
2. An electro-mechanical device called the Filtrate BioScanner that
measures glucose levels in the ultrafiltrate collected via the CFC.
The Polymer Technology Systems CFC device will be used on hospital based
patients initially. The system can be programmed to run a test as often as
every 2 minutes. The initial clinical studies will be performed on diabetic
surgical patients. The CFC will be inserted in pre-op, follow the patient
with correlating fingerstick glucose in the operating room, and then follow
the patient for an additional 2 hours in post-op.
Due to the high vacuum used to remove the filtrate from the proximity of
the capillary bed, the actual static interstitial fluid will be "removed" by
early sampling and almost real time (5 - 10 minutes) correlation with actual
blood glucose could then occur. This type of fluid sampling system will not
be impacted by surface skin "sweat" as other "Outside the body sample
collection" device systems.
Second generation product will include the measurement of ketone
simultaneously with glucose in the emergency room environment for the
treatment of diabetic keto-acidosis (DKA).
This second generation product will next be introduced to help diabetics
monitor blood glucose at home, work or play without the several times daily
current regimen of sticking ones finger to draw blood. Furthermore,
inadequate monitoring of glucose levels leading to poor glucose control in the
patient is the causative factor in the long-term complications associated with
diabetes such as renal disease, amputations and blindness. Currently, the
most common method available to the diabetics for monitoring their glucose
levels is to prick their fingers to obtain a blood sample to be tested with an
instrument such as a Glucometer. This is a painful method for the patient,
especially when multiple tests must be performed every day. Hence, few
patients follow the recommended schedule exactly and the noncompliance leads
to the failure in self-monitoring of blood glucose in the patient. An
implantable glucose sensor that can be worn continuously by the patient and
provide constant monitoring of glucose levels could significantly improve
control of diabetes in the patient.
Much discussion has taken place recently on the subjects of non-invasive
and minimally invasive testing of glucose levels in diabetics, but the fact is
that these systems will not be available in the near future or have not yet
been proven viable for a home system, respectively. This year's Oak Ridge
Conference (an internationally known conference held every year and attended
by top scientists in the field from around the world to assess and present
studies and review the status of new technologies) main topic was "On the Road
to Non-Invasive Testing." The conspicuous absence of the companies that have
been claiming great progress in the non-invasive area was noticeable to this
year's attendees. The panel's conclusion regarding non-invasive testing noted
that it might be possible, but not until spectrophotometric technologies are
improved, and it might even have to be a combination of technologies. It will
not happen in the near future.
Comments at the Oakridge Conference on other procedures for the
measurement of interstitial fluids are as follows:
Non-Invasive using Patch method or interstitial fluid:
A number of presentations were given; one presentation stated that due
to the variation of sweat mixing with interstitial fluid the patch
method was probably useful for qualitative tests but would not be useful
Two presentations on minimally-invasive testing using interstitial fluid
were from presented:
One system consisted of an electro-chemical sensor implanted under the
skin and left in place for three days. Its use would be by physician
only and would only be useful for supplemental data since it has to be
calibrated by at least 4 regular finger sticks with a strip and meter
system each day.
The other system presented was good but only included fasting glucose
values. No data was presented using real world data on a final
prototype where the extraction portion and testing portion were
Polymer Technology Systems, Inc., is a privately owned company located on
the northwest side of Indianapolis. Incorporated in 1992, PTS delivers
leading edge, point of care diagnostics to the health care market catering to
both physicians' offices and the home consumer.
SOURCE Polymer Technology Systems, Inc.