SI-BONE partners with customers to provide further assurance of product safety and effectiveness as demonstrated in almost 50 peer-reviewed published papers
SAN JOSE, Calif., Jan. 9, 2017 /PRNewswire/
-- SI-BONE, Inc., an innovative medical device company that pioneered the
use of the iFuse Implant System® ("iFuse"), a triangular shaped
minimally invasive surgical (MIS) device indicated for fusion for certain
disorders of the sacroiliac (SI) joint, announced a revolutionary iFuse
warranty program. The new warranty goes beyond guaranteeing the integrity
of the product by focusing on actual procedure-related outcomes and positive
patient results. Although revisions of SI joint fusion procedures with iFuse
have been shown to be low1-3, this new warranty will provide users with a free
iFuse Implant™ to either supplement or replace previously placed iFuse Implants
within a one-year period following the initial or index procedure, should a
revision be required. In addition, for any revision procedure that occurs
within the one-year warranty period that does not require a supplemental or
replacement iFuse Implant, the warranty provides a one-time credit towards an
iFuse Implant for use in a future iFuse Procedure™. Terms and conditions
of the new warranty are available at https://si-bone.com/warranty/
"This is a ground-breaking warranty within our
industry, which is based on the integrity of our product and focused on actual
patient outcomes," said Jeffrey Dunn, President and CEO of SI-BONE.
"Our warranty illustrates the confidence we have in our product and
procedure based on the almost 50 positive iFuse clinical publications,
extensive practical experience of nearly 24,000 iFuse surgeries and our
industry-leading medical education and field teams. When I meet with
providers, there is a common interest expressed in that hospitals and payors
don't want to pay for competitive products when they have no idea what the
results, revision rates or durability will be. Our warranty further
demonstrates our uncompromising commitment to these health care providers and
their patients."
The iFuse Implant offers a unique advantage for stabilizing
and fusing the SI joint as a result of its patented triangular shape and large
porous surface area. The triangular shape provides more than 31 times the
rotational resistance of a screw which stabilizes the joint while the large
porous surface area provides an ideal environment for bony on-growth* to
support long-term fusion.
"Reducing revision surgeries and associated hospital readmissions
is becoming increasingly important as hospitals gravitate toward 'pay for
performance' reimbursement models," said Peter Whang, MD, FACS and
Associate Professor in the Department of Orthopaedics and Rehabilitation at the Yale
University School of Medicine. "The iFuse warranty program is a
great example of how leading companies like SI-BONE can partner with health
care providers to lower costs and share risks associated with patient
care."
About SI-BONE, Inc.
SI-BONE, Inc. (San
Jose, California) is a leading innovative medical device company dedicated to
the development, manufacture and commercialization of minimally invasive
surgical devices for the treatment of patients with low back symptoms related
to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received
510(k) clearance to market its iFuse Implant System ("iFuse") from
the Food and Drug Administration (FDA) in November 2008. The CE mark for
European commercialization was obtained in November 2010.
The iFuse Implant System provides a minimally invasive
surgical solution to fuse the SI joint using patented triangular titanium
implants that create an interference fit within the ilium and sacrum. The
triangular implant shape, combined with the press fit insertion, is designed to
provide immediate fixation by minimizing rotational motion. The implants
have a porous surface that provide an ideal environment for bone on-growth and
ingrowth, facilitating long-term fusion of the joint*. iFuse is the only
commercially available SI joint fusion system in the United States with
published prospective clinical evidence that demonstrates safety, effectiveness
and economic benefits, including three large multicenter studies, two of which
are randomized controlled trials. Currently, there are more than 45
peer-reviewed publications supporting positive clinical outcomes, safety,
biomechanics, and the economic value of iFuse (www.si-bone.com/results).
It is the only SI joint fusion system with a FDA clearance recognizing
demonstrated improvements in pain, patient function and quality of life
following treatment.
The iFuse Implant System is intended for sacroiliac fusion
for conditions including sacroiliac joint dysfunction that is a direct result
of sacroiliac joint disruption and degenerative sacroiliitis. This
includes conditions whose symptoms began during pregnancy or in the peripartum
period and have persisted postpartum for more than 6 months. Clinical
studies have demonstrated that treatment with the iFuse Implant System improved
pain, patient function, and quality of life. There are potential risks
associated with the iFuse Implant System. It may not be appropriate for
all patients and all patients may not benefit. For information about the
risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks
of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9756.010917
*Data on file: TR 300401-A and 300359-A
1. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser
JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group.
Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive
Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint
Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028.
2. Duhon B, Bitan F, Lockstadt H, Kovalsky D, Cher D,
Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for
Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective
Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. doi: 10.14444/3013.
3. Cher DJ, Reckling WC, Capobianco RA. Implant
Survivorship Analysis after Minimally Invasive Sacroiliac Joint Fusion using
the iFuse Implant System. Med Devices (Auckl). 2015;8:485-92. doi:
10.2147/MDER.S94885.
One or more of the individuals named herein may be a past or
present SI-BONE employee, paid consultant, investor, clinical trial
investigator, or grant recipient. Research described herein was supported by
SI-BONE.
Published at PRNewsWire
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