Ceterix Orthopaedics Announces FDA Clearance of the NovoStitch Pro Meniscal Repair System, Offering Enhanced Features to Impr...
16 April 2018 - 11:00PM
Business Wire
Meniscus surgery is one of the most common
surgical procedures in the United States, with one million
performed annually
Ceterix® Orthopaedics, Inc., a leader in the
development of cutting-edge surgical tools for orthopaedic
surgeons, today announced U.S. Food and Drug Administration (FDA)
clearance of the company’s NovoStitch® Pro Meniscal Repair
System. This next-generation meniscal repair system is a
significant product evolution, offering enhanced technical features
to improve the ease of use and workflow for the surgeon.
Ceterix’s NovoStitch systems enable surgeons to place stitches
arthroscopically in tight joint compartments, allowing them to
address complex meniscal tears that have not been amenable to
repair in the past. Enhancements in the newly FDA-cleared
NovoStitch Pro system include an ergonomic and intuitive handle
design, the addition of well-defined visual cues for precise stitch
placement, and improved control and stability from upper jaw
texturing.
“The new NovoStitch Pro meniscal repair system represents a
significant improvement to one of the most innovative technologies
developed for arthroscopic knee repair,” said Dr. Peter Kurzweil,
president of Memorial Orthopaedic Surgical Group in Long Beach,
Calif. “The technological enhancements incorporated into the new
system offer the potential to repair tear types that were
previously considered difficult or impossible to sew, with improved
control and access for the surgeon. I look forward to incorporating
it into my practice.”
The meniscus is a crescent of soft cartilage resting between the
femur and tibia that cushions the knee and provides stability to
the joint. Meniscal tears are one of the most frequently occurring
knee injuries and are most often treated by a procedure called a
meniscectomy, in which a surgeon removes the torn tissue.
Meniscectomy has been shown to increase a patient’s risk of
developing osteoarthritis, which may lead to total knee replacement
later in life. A 2015 health economics study determined that
effective meniscal repair can result in long-term cost savings vs.
meniscectomy due to the reduced risk of requiring costly future
interventions1.
“This FDA clearance is another important milestone in our
mission to reduce the number of meniscectomies and to save the
meniscus,” said John McCutcheon, Ceterix’s president and CEO.
“Ceterix continues to be the leader in meniscal repair by providing
innovations that preserve tissue and sustain the natural
biomechanics of the knee joint.”
Arthroscopic surgery is a minimally-invasive procedure in which
an orthopaedic surgeon treats a damaged joint through small
incisions using specialized tools guided by a tiny camera called an
arthroscope. Meniscus surgery is the most common arthroscopic
procedure in the United States, with roughly one million performed
annually2,3.
About Ceterix® Orthopaedics
Ceterix® Orthopaedics develops surgical tools that fill
unmet clinical needs for physicians who treat soft tissue joint
injuries such as meniscus tears. Founded in 2010 with the vision of
improving outcomes of arthroscopic procedures, Ceterix’s novel
meniscal repair system enables surgeons to place suture patterns
that were previously only possible in open procedures, or not at
all. The NovoStitch® Pro Meniscal Repair System has received
510k clearance in the United States and is indicated for
approximation of soft tissue in meniscal repair procedures. The
company is based in Fremont, Calif., and is backed by investors
Versant Ventures, 5AM Ventures, and CRG. For more information,
please visit www.ceterix.com and follow us at @ceterix on
Twitter.
1 Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair
versus Partial Meniscectomy: A Model-based Projection of Clinical
Outcomes and Costs in the United States Healthcare System. ISPOR
Annual Meeting 2015.2 Brinker MR, O'Connor DP, Pierce P, Woods GW,
Elliott MN. Utilization of orthopaedic services in a capitated
population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.3 New
Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New
Hampshire Comprehensive Health Care System; 2006.
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for Ceterix Orthopaedics, Inc.Krysta
PellegrinoKrysta@healthandcommerce.com