THOUSAND OAKS, Calif.--(BUSINESS WIRE)--
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
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