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NEWLY AVAILABLE, NEWLY APPROVED
Bicompartmental Knee Resurfacing
System
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ConforMIS, Inc. announced the launch
of a patient-specific bicompartmental
knee resurfacing implant. The iDuo
is a bicompartmental resurfacing implant
designed for patients whose arthritic
damage is limited to either the medial
or lateral compartment of the knee,
in addition to the patellofemoral
compartment. ConforMIS emphasizes
that the iDuo resurfaces only the
affected areas, preserving far more
bone on both the femur and tibia than
traditional knee replacement surgery.
The iDuo also preserves both the anterior
and posterior cruciate ligaments,
helping to maintain natural knee kinematics.
The extent of tissue preservation
with the iDuo helps patients retain
their future surgical options. The
implant is 510(k) cleared for marketing
by the US Food and Drug Administration.
The iDuo was developed for patients
with advanced osteoarthritis affecting
one of the tibiofemoral compartments
along with the patellofemoral compartment.
The bone-and cartilage-preserving
features
of the iDuo may be especially valuable
for young and active patients for whom
traditional knee replacement is considered
too early, but who suffer from arthritis
in one or two compartments. The
iDuo allows the patient to preserve
their joint for future surgical options,
while receiving an implant with the
potential to prevent or delay the need
for a more invasive surgery.
The ConforMIS iDuo is intended for use
in patients with severe knee joint pain
and disability whose conditions cannot
be solely addressed by the use of a
prosthetic device that treats only a
single knee compartment, such as the
unicondylar or patellofemoral prosthesis.
The indications for use include restoring
joint function and relief of pain due
to painful joint disease caused by osteoarthritis,
traumatic arthritis, or rheumatoid arthritis
of the knee; posttraumatic loss of joint
function; and failed osteotomies, hemiarthoplasties,
and unicondylar implants. The iDuo may
be utilized when the medial or lateral
condyle and the patellofemoral areas
have been affected by one or more of
these conditions.
To learn more, contact
ConforMIS, Inc.
2 Fourth Ave., Burlington
MA, 01803
phone (781) 860-5111; fax (781) 860-5108
www.conformis.com |
Nitinol Implant
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BME (BioMedical Enterprises, Inc.) has launched the Barbed OSStaple™ (BOSS), a nitinol implant designed for
internal fixation of bone. The BOSS is an orthopedic nitinol implant with
barbs on the legs for bone adhesion. Like the BME OSStaple™ product
line, the BOSS nitinol staple changes shape when heated above body temperature
to provide compression between 2 bones. The BOSS is ideal for upper and
lower extremity procedures, especially when surgeons want the added security
of barbed legs to stabilize the implant.
Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic
properties, the BOSS implant is inserted at room temperature. Using BME’s
patented OSSforce™ Implant Controller, the implant is safely heated above
body temperature. During this process, the implant’s legs and back
change shape to compress bone. In addition, the movement of the legs causes
the barbs to anchor more securely in bone. After heating, the nitinol structure
transforms into a state approximately 20% stronger than 316L stainless steel. Because
of nitinol’s unique properties, the implant continues to maintain a compressive
force in bone over time.
The BOSS implant, along with BME’s OSSAnchor™ Grip soft tissue anchor,
are the first orthopedic nitinol implants to feature barbs for improved pull-out
resistance, a new surface treatment that minimizes metal ion release, and a roughened
surface texture for bone in-growth.
To learn more, contact
BioMedical Enterprises, Inc.
Texas Research Park, 14785 Omicron Dr., Suite 205
San Antonio, TX 78245
www.bme-tx.com
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Synthetic Bone Graft
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NovaBone Products, LLC (NBP) has released a new form of the synthetic bone graft,
NovaBone Putty® (bone graft substitute). NovaBone®, a calcium-phosphate
silicate, goes through an ionic dissolution process that signals the body to
send more precursors to the wound site earlier and forms an apatite surface
layer that acts as a framework for osteoblast attachment and new bone formation.
This results in an increase in osteoblast function over the first few weeks.
The US Food and Drug Administration has approved the term osteostimulation to
describe NovaBone’s capability. NovaBone is the only synthetic that is
osteostimulative, directly increasing the proliferation and activity of osteoblasts.
The company notes that this results in more extensive early bone formation than
seen for other synthetic graft materials when evaluated during in vivo testing.
For more information, contact
NovaBone Products, LLC
1551 Atlantic Blvd, #105, Jacksonville
FL, 32207
phone (904)807-0140; fax (904) 807-0141
www.NovaBone.com
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Suture Anchor for Arthroscopic Hip Repair
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ConMed Corporation’s Linvatec arthroscopy unit announced that the US Food
and Drug Administration has cleared its 510(k) application for marketing of the
Bio Mini-Revo™ suture anchor for use in the repair of the labrum in the
hip joint.
The Bio Mini-Revo™ anchor is a bioabsorbable 3.1mm diameter screw-in anchor
manufactured from Conmed Linvatec’s patented Self Reinforced 96L/4D Poly
Lactic Acid. This unique material provides an optimal balance of strength (during
the initial postsurgery healing period) with enhanced resorption over time, negating
the need for a second surgery to remove the implant. The anchor is pre-threaded
with #2 Hi-Fi® high-strength suture.
The Bio Mini-Revo™ anchor joins a growing number of products in the ConMed
Linvatec Hip Arthroscopy line, including disposable hip access kits, cannulas,
Shutt brand manual instruments, microfracture awls, shaver blades and burrs,
and imaging and pump systems.
For more information, contact
CONMED Corporation
525 French Road
Utica, NY 13502
phone (800) 237-0169; fax (727) 399-5256
www.conmed.com
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New Surgical
System
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ROBODOC®, a CUREXO Technology Company announced that under the name of its
predecessor, Integrated Surgical Systems, Inc., it received 510(k) clearance
from the US Food and Drug Administration for its DigiMatch™ ROBODOC® Surgical
System.
The newly cleared system delivers a precise, repeatable surgical technique to
prepare the joint for hip replacement procedures. The process allows the surgeon
to select an ideal implant from multiple implant manufacturers after reviewing
a detailed CT scan of the patient’s joint. The company notes that, utilizing
the proprietary system software, surgeons can preview the surgical outcome before
beginning the actual operation.The robotic assistant has been used in over 24,000
joint replacement procedures worldwide and is shown to be less traumatic for
patients and more precise than manual preparation techniques. In total hip surgery
applications, the ROBODOC system executes exact bone cutting and precise implant
placement to reduce surgical fractures and complications and minimize human error.
For more information, contact
ROBODOC®, A CUREXO Technology Company
1433 N. Market Blvd., Suite 1
Sacramento, CA 95834
phone (916)285-9943 x 527
www.robodoc.com
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