PRESS RELEASES
CARTICEPT MEDICAL™ RECEIVES FDA CLEARANCE FOR AUTOMATED
INJECTION SYSTEM
WITH INTEGRATED ULTRASOUND GUIDANCE
(Alpharetta, GA, October 4, 2011)--Carticept Medical, Inc., a developer
of innovative products for the treatment
of cartilage injuries
and osteoarthritis, today announced
that it has received 510(k) clearance from the Food and
Drug
Administration to market its Navigator™ Delivery System (Navigator
DS) in the United States. The
Navigator DS is a
computer-controlled drug delivery system with integrated ultrasound
guidance designed to
increase the efficiency, accuracy and safety
of administering pain-relieving medications for joint pain.
Arthritis is the leading cause of disability in the United States
with more than 46 million Americans having
doctor-diagnosed
arthritis.1 Local injections of
corticosteroids and anesthetic agents are heavily relied on as
early,
effective interventions for pain relief. The current
standard of practice depends on the expertise of the clinician
and the accuracy with which the medications are injected into the
affected joint space. According to a recent study
published in
The American Journal of Sports Medicine,
injection accuracy rates are significantly higher when
imaging is
used in conjunction with injection of the knee and shoulder.
“Minimally invasive and cost-effective injections can delay and in
some cases eliminate the need for surgical
intervention,” said
John S. Reach, Jr., M.Sc., M.D., director of the Yale Foot and Ankle
Section and assistant
professor in the department of Orthopaedic
Surgery, Yale University School of Medicine, New Haven, Conn.
“Recent studies have demonstrated greater accuracy with improved
function and decreased pain in patients
receiving
ultrasound-guided injections. The
Navigator DS automatically prepares the medication dose, guides
accurate needle positioning prior to drug delivery, and simplifies
record-keeping—allowing me to spend more
quality time with each
patient.”
The Navigator DS is a comprehensive drug delivery system for
convenient operation by a single clinician. The
Navigator DS
prepares and delivers physician-prescribed injections from standard
multi-dose anesthetic and
steroid drug vials, eliminating needle
exposures to healthcare workers and minimizing the potential for
contamination of the medication. Additionally, the automated system
helps to ensure accurate dose preparation
and saves significant
labor for a busy physician practice. The ultrasound screen provides
the physician with realtime
visualization of the needle position,
fluid delivery process and prescription volume. After the injection
is
delivered, the system records the treatment data and
automatically creates a record for transfer to an electronic
record management system.
“The Navigator DS has the potential to change the standard of care
for injection procedures,” said Charles E.
Garten II, M.D.,
director of Primary Care Sports Medicine at Myers Sports Medicine
and Orthopaedic Center in
Atlanta. “The Navigator DS simplifies
the set-up of multi-drug injections, while the integration with
ultrasound
imaging provides me with real-time feedback regarding
the accuracy of the needle placement. Automating the
manual steps
of procedures will ultimately help improve patient care, increase
efficiency and maximize patient
throughput in the sports medicine
clinic.”
“The FDA clearance of the Navigator DS provides physicians with a
complete, computer-controlled intelligent
injection system,” said
Timothy J. Patrick, president and chief executive officer of
Carticept. “In addition to its
use in sports medicine and
orthopaedics, we believe the technology has future applications in
anesthesiology,
radiology and other specialties that require
accurate dose delivery.”
About Carticept Medical, Inc.
Based in Alpharetta, Ga., Carticept Medical, Inc. is a privately
held medical device company established in 2005
to develop and
market innovative solutions for patients with osteoarthritis or
cartilage damage. Major investors
include Domain Associates, New
Enterprise Associates and SonoSite, Inc. Additional information is
available on
the company’s website at
www.carticept.com.
Media Contacts:
Krystin Hayward/Rachel Gross
carticept@schwartzmsl.com
781-684-0770
1Arthritis: Meeting the
Challenge. Atlanta, GA: National Center for Chronic Disease
Prevention and
Health Promotion; 2009.
[http://www.cdc.gov/NCCDPHP/publications/aag/pdf/arthritis.pdf]
|
|
|
