LITTLE FALLS, N.J. and
CLEVELAND, May 28, 2014 /PRNewswire/ -- Cantel Medical Corp.
(NYSE: CMN) and OsteoSymbionics, a leading designer and
manufacturer of innovative, patient-specific craniofacial implants,
are pleased to announce FDA (U.S. Food and Drug Administration)
510(k) clearance of OsteoSymbionics' signature ClearShield™ product
made from Polymethyl methacrylate (PMMA). ClearShield™ is the
first Class II medical device cleared by the FDA utilizing
REVOX® Sterilization Solutions' room temperature
peracetic acid/hydrogen peroxide (PAA) vacuum vapor sterilization
process. ClearShield™ implants are used in patients who have
suffered trauma to the skull, restoring the protective and cosmetic
features of the individual's own bone.
Dorothy Baunach, CEO of
OsteoSymbionics says, "REVOX® is the perfect solution
for the sterile processing of our ClearShield™ craniofacial
implants. More and more hospitals are discontinuing on-site use of
ethylene oxide (EtO) sterilization and we needed a solution
that would offer fast contract service turnaround and potential for
processing at our manufacturing site as well. After much research
into sterile processing options we discovered REVOX®, with the
right technology and all the resources we needed to help our small,
but well-respected company, work toward this ideal solution."
Jorgen Hansen, COO of Cantel
Medical comments, "We are pleased that REVOX®
Sterilization Solutions is able to facilitate the use of this
innovative and critically important device. With increasing
sophistication of medical, diagnostic, drug delivery, and
implantable devices, REVOX is a timely alternative for
manufacturers such as OsteoSymbionics. This 510(k) clearance
underscores the safety and efficacy of the REVOX sterilization
process and more broadly, our new product and market expansion
capabilities within Cantel."
About OsteoSymbionics
OsteoSymbionics is dedicated to the design, development and
fabrication of the highest quality patient-specific craniofacial
implants for patients with severe cranial and facial damage. The
company's hard-tissue implants are used by top surgeons at
America's leading hospitals and abroad. More than 850
patients have benefitted from ClearShield™ (PMMA) and PK-Shield™
implants made from Polyether ether ketone (PEEK). OsteoSymbionics
also makes a silicone product, STT™, designed to correct temporal
hollowing.
Using state-of-the-art digital technology and custom software,
our biomedical engineering experts work closely with classically
trained sculptors and artisans to create implants that precisely
match both the surgeon's plan and the patient's needs. Cases
requiring implants above average in size or difficulty of design
are a specialty.
OsteoSymbionics is an awarded supplier of its
Craniomaxillofacial (CMF) products to Novation, a premiere group
purchasing organization serving more than 60,000
members.
Founded and located in Cleveland,
Ohio, OsteoSymbionics is active in the region's vibrant
community of businesses focused on bioscience technologies and
health care services and products. The company is housed
within the multi-tenant facility of the Manufacturing Advocacy and
Growth Network (MAGNET).
For more information about OsteoSymbionics and its products,
please call 877-881-6899 or visit our website at
www.osteosymbionics.com
About REVOX® Sterilization Solutions
Collaboratively developed and marketed by Cantel subsidiaries
Medivators and Mar Cor Purification, REVOX Sterilization Solutions
offers the first commercially available room temperature vapor
sterilization process. With full contract validation and
sterilization services as well as on-site processing potential with
multiple chamber configurations, REVOX Sterilization Solutions is
positioned to foster increased innovation and production
efficiencies for manufacturers of advanced devices.
For more information, please visit our website at
revoxsterilization.com.
About Cantel Medical Corp.
Cantel Medical (NYSE: CMN) is a leading global company dedicated
to delivering innovative infection prevention and control products
and services for patients, caregivers, and other healthcare
providers which improve outcomes, enhance safety and help save
lives. Our products include specialized medical device
reprocessing systems for endoscopy and renal dialysis, advanced
water purification equipment, sterilants, disinfectants and
cleaners, sterility assurance monitoring products for hospitals and
dental clinics, disposable infection control products primarily for
dental and GI endoscopy markets, dialysate concentrates, hollow
fiber membrane filtration and separation products, and specialty
packaging for infectious and biological specimens. Additionally, we
provide technical service for our products. For further
information, visit the Cantel website at www.cantelmedical.com.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements involve a number of risks and uncertainties,
including, without limitation, the risks detailed in Cantel's
filings and reports with the Securities and Exchange Commission.
Such forward-looking statements are only predictions, and actual
events or results may differ materially from those projected or
anticipated.
SOURCE Cantel Medical Corp.