ECA Medical Instruments Develops First Disposable Spinal Instrument Fixation Kit to Gain FDA Approval with Intelligent Implan...
January 16 2015 - 7:00AM
Business Wire
Intelligent Implant Systems Revolution Spinal System™ features
ECA’s sterile packed, disposable instrument set to ease workflow,
save cost and boost OR efficiency in inpatient and outpatient
settings.
ECA Medical Instruments, the leading designer and manufacturer
of single-procedure torque-limiting and fixed-driver surgical
instruments and procedural kits, developed the industry’s first
fully disposable spine implant fixation instrument kit to gain FDA
approval, the company announced today. The industry-first
disposable spine implant fixation kit has been granted FDA 510(k)
approval to be used with the Intelligent Implant Systems (IIS)
Revolution Spinal System™ and will be available in the marketplace
starting second quarter 2015.
World's first disposable spine implant
fixation kit receives FDA approvals. ECA Medical Instruments
developed this novel sterile packed ready for surgery instrument
kit, which includes critical torque-limiters, fixed drivers and
plate holders, providing healthcare cost savings and greater OR
efficiency for both hospitals and surgery centers. (Photo: Business
Wire)
The sterile-packed kit features a full complement of fixation
instruments in a single sterile packed tray including proprietary
and industry first cannulated torque-limiters, ratchets and fixed
drivers. These specialized instruments are needed by surgeons to
perform both open and minimally invasive surgeries (MIS) in both
inpatient and outpatient facilities.
“This single tray of instruments is game changing for our
industry and FDA approval signals a new era is taking hold with
potential to transform healthcare economics,” said John Nino,
president and CEO of ECA Medical Instruments. “Surgeons, hospitals,
ambulatory surgical centers (ASCs) and patients all benefit from
cost savings, increased safety and superb outcomes. The IIS
Revolution™ set with ECA’s instruments was designed to make that
sustained and measurable value a reality,” he said.
The IIS Revolution Spinal System™ offers a simplified design for
posterior spinal fixation implant of single or two-level constructs
providing hospitals and ASCs a novel pre-sterile implant and
instrument set combination to increase productivity, reduce
operational cost, insure accurate implant fixation and curb risk of
surgical site infection. The spine implants and instruments are
packaged as a bundled solution. The IIS implants provide
immobilization and stabilization of spinal segments in skeletally
mature patients as an adjunct to fusion in the treatment of acute
and chronic instabilities or deformities of the thoracic, lumbar
and sacral spine.
“We are excited to be launching the Revolution™ Spinal System,
and the feedback from surgeons, distributors, OR staff and sales
people has been exceptional. By providing sterile state-of-the-art
implants combined with a single sterile tray of disposable
instruments by ECA, we are leading the way to a better approach for
spinal surgery,” said Marc Richelsoph, President and CEO of
Intelligent Implant Systems, LLC.
All ECA instruments for the Revolution™ spinal fusion kit are
single-procedure and disposable, simplifying workflow by
eliminating the need to clean and reprocess instruments prior to
every procedure. Single-procedure instruments minimize the risk of
infection due to cross contamination, ensuring pristine out of the
box instruments are used to support every patient procedure. The
kit contains 100% disposable fixation tools including awls, pedicle
probes, driver shafts and industry first cannulated torque-limiting
handles, ratchet and fixed driver making them ideal for MIS
procedures.
With this FDA approval IIS will rapidly advance the Revolution
Spinal System™ with its distributors throughout North America.
Focus will be on serving ASCs as well as hospitals. All the kits
and instruments are disposable, biodegradable or recyclable.
About ECA Medical Instruments
ECA Medical Instruments, an American Capital company
(NASDAQ:ACAS), was founded in 1979 and located in Thousand Oaks,
CA. ECA is the medical industry leader in single-procedure
torque-limiting instruments and surgical fixation kits. The company
has manufactured and delivered over 25 million precision torque
instruments to the world’s leading producers of CRM,
neuromodulation, cardiovascular and orthopaedic and spine implants
resulting in over 500 million precision surgical actuations. Every
20 seconds of every day an ECA torque instrument is used to secure
a medical implant—one patient at a time. ECA is an ISO 13485, CE
Mark certified and FDA registered company and was named Business of
the Year 2012 by the Pacific Coast Business Times.
www.ecamedical.com
About Intelligent Implant Systems
Based in Charlotte, North Carolina, Intelligent Implant Systems
was founded with the goal to develop and market innovative surgical
solutions for orthopedics and both fusion and non-fusion
applications of the spine. Since its inception, Intelligent Implant
Systems has been granted multiple US patents with foreign and
additional US patents pending to protect its core technology. The
product portfolio includes implants and instrumentation for
enhanced fixation technology, facet joint fusion, lumbar posterior
fusion, deformity correction, cervico-thoracic posterior fusion,
and lumbar interbody fusion. www.intelligentimplantsystems.com
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20150116005059/en/
ECA Medical InstrumentsJames B. Schultz,
+1-805-990-6177Executive Vice Presidentjschultz@ecamedical.com
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