Engineered for precision, confidence and efficiency in
surgery - and compatible with the CORI◊ Surgical
System
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology
company, today announces it has received 510(k) clearance for its
new CATALYSTEM Primary Hip System from the United States Food and
Drug Administration. The system is designed to address the evolving
demands of primary hip surgery including the increased adoption of
anterior approach procedures and the expanding role of Ambulatory
Surgery Centers (ASCs).
Advancements in primary hip arthroplasty include a shift to a
shorter, proximally filling stem that is easier to prepare and
insert using the direct anterior approach – a less invasive
procedure that may enable improved range-of-motion and faster
recovery for patients.1,2 This segment fits a diverse range of
patient anatomies and is rapidly growing at a compound annual
growth rate >10%.
Building on the heritage of Smith+Nephew’s clinically successful
stem designs,3,4 the CATALYSTEM Primary Hip System was developed
using global data sets across femoral morphologies to help deliver
a precision fit.5,6 Featuring a triple-taper stem design with
uniform proximal loading,7 the reduced distal stem geometry and
shorter lengths are ideal for anterior approach but suitable for
all approaches.8
“The design of CATALYSTEM facilitates accurate fit and fill
proximally without distal interference. It is ideally suited for
the direct anterior approach and caters to the diverse needs of my
patients,” said George Haidukewych MD, Orlando Health, Orlando,
Florida and a contributor in the systems design. “Additionally, the
system is delivered in a single modular tray, tailored to my
surgical approach. This helps drive efficiencies in facilitating
more shelf space and reducing sterilization costs - perfect for my
ASC setting.”
The CATALYSTEM Primary Hip System also utilizes proprietary,
patent-pending, ACCUBROACH◊ Technology delivering
proven reproducibility between broach and implant giving confidence
in predictable and reproducible stem seating.9,10
Don Garbuz, President of the Hip Society, Vancouver, Canada and
a contributor in the systems design said, “We wanted to give
surgeons confidence in broach to implant relationship; the implant
reproducing where the broach was seated. During the design process,
we put in a lot of time developing ACCUBROACH Technology with
various tooth patterns to ensure we could duplicate excellent axial
and rotational stability and validated that the stem sits exactly
where we want it. We’re extremely pleased with the outcome.”
“Building on the strong clinical heritage of POLAR3◊, our
CATALYSTEM Primary Hip System represents a significant milestone
for Smith+Nephew’s hip business, complementing our current hip
portfolio with a primary stem ideal for advanced anterior
approaches, said Craig Gaffin, President Global Orthopaedics for
Smith+Nephew. “Engineered for precision, confidence and surgical
efficiencies, the launch of this new stem combined with our
proprietary, market leading OXINIUM◊ Technology and integration
with our robotics platform will help Smith+Nephew continue to
enhance patient outcomes in hip surgery.”
To learn more about Smith+Nephew’s new CATALYSTEM Primary Hip
System for total hip arthroplasty, please visit
https://www.smith-nephew.com/en/health-care-professionals/products/orthopaedics/catalystem.
- ends –
Enquiries
Media Dave Snyder
+1 (978)
749-1440 Smith+Nephew
References
- Kyriakopoulos G, Poultsides L, Christofilopoulos P. Total hip
arthroplasty through an anterior approach: The pros and cons. EFORT
Open Rev. 2018 Nov 1;3(11):574-583.
- Ang JJM, Onggo JR, Stokes CM, Ambikaipalan A. Comparing direct
anterior approach versus posterior approach or lateral approach in
total hip arthroplasty: a systematic review and meta-analysis. Eur
J Orthop Surg Traumatol. 2023 Oct;33(7):2773-2792
- Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem:
Synergy. Internal Report. 10143364 REV A
- Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem:
POLARSTEM. Internal Report. 10143423 REV A
- Smith + Nephew 2024 CATALYSTEM Summary of Global Evaluations.
Internal Report. 10143591
- Smith + Nephew 2024. Three-dimensional assessment stem fit and
restoration of natural biomechanics in a globally diverse
population of femoral CT scans. Internal Report. TM-24-034
- Smith + Nephew 2024. Finite Element Analysis of the CATALYSTEM
Hip Stem Design. Internal Report. OR-24-025
- Smith + Nephew 2024. Surgeon Feedback on the CATALYSTEM Total
Hip System. Internal Report. CSD.REC.24.001
- Smith + Nephew 2024. Cadaveric study of the repeatability of
CATALYSTEM broach and femoral stem seating level. Internal Report.
10144794
- Smith + Nephew 2024. CATALYSTEM Accubroach Femur to Bone
Interaction Design Rationale. Internal Report. 10142827
This material is provided for informational purposes only and is
not intended to serve as medical advice. It is the
responsibility of operating physicians to determine and utilise the
appropriate products and techniques according to their own clinical
judgment for each of their patients. The clinician
testimonials set out in this material represent the individual
clinician’s own opinions, findings, beliefs, and/or
experiences. Individual results will vary. he
clinicians featured were involved in the development of CATALYSTEM
and were compensated by Smith+Nephew for their time. To review
the information needed to understand and use CATALYSTEM safely and
effectively, including indications for use, contraindications,
effects, precautions, and warnings, please consult the product’s
applicable Instructions for Use (IFU) prior to use. The
information presented in this material may not be appropriate for
all markets. Products featured may not be available due to
regulatory and/or medical practices in individual markets. Please
contact your Smith+Nephew representative if you have questions
about availability of Smith+Nephew products in your area.
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused
on the repair, regeneration and replacement of soft and hard
tissue. We exist to restore people’s bodies and their self-belief
by using technology to take the limits off living. We call this
purpose ‘Life Unlimited’. Our 18,000 employees deliver this mission
every day, making a difference to patients’ lives through the
excellence of our product portfolio, and the invention and
application of new technologies across our three global
business units of Orthopaedics, Sports Medicine & ENT and
Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in more than 100
countries, and generated annual sales of $5.5 billion in 2023.
Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN).
The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith
& Nephew plc and its consolidated subsidiaries, unless the
context requires otherwise.
For more information about Smith+Nephew, please visit
www.smith-nephew.com and follow us on X, LinkedIn, Instagram
or Facebook.
Forward-looking Statements
This document may contain forward-looking statements that
may or may not prove accurate. For example, statements regarding
expected revenue growth and trading profit margins, market trends
and our product pipeline are forward-looking statements. Phrases
such as "aim", "plan", "intend", "anticipate", "well-placed",
"believe", "estimate", "expect", "target", "consider" and similar
expressions are generally intended to identify forward-looking
statements. Forward-looking statements involve known and unknown
risks, uncertainties and other important factors that could cause
actual results to differ materially from what is expressed or
implied by the statements. For Smith+Nephew, these factors include:
conflicts in Europe and the Middle East, economic and financial
conditions in the markets we serve, especially those affecting
healthcare providers, payers and customers; price levels for
established and innovative medical devices; developments in medical
technology; regulatory approvals, reimbursement decisions or other
government actions; product defects or recalls or other problems
with quality management systems or failure to comply with related
regulations; litigation relating to patent or other claims; legal
and financial compliance risks and related investigative, remedial
or enforcement actions; disruption to our supply chain or
operations or those of our suppliers; competition for qualified
personnel; strategic actions, including acquisitions and disposals,
our success in performing due diligence, valuing and integrating
acquired businesses; disruption that may result from transactions
or other changes we make in our business plans or organisation to
adapt to market developments; relationships with healthcare
professionals; reliance on information technology and
cybersecurity; disruptions due to natural disasters, weather and
climate change related events; changes in customer and other
stakeholder sustainability expectations; changes in taxation
regulations; effects of foreign exchange volatility; and numerous
other matters that affect us or our markets, including those of a
political, economic, business, competitive or reputational nature.
Please refer to the documents that Smith+Nephew has filed with the
U.S. Securities and Exchange Commission under the U.S. Securities
Exchange Act of 1934, as amended, including Smith+Nephew's most
recent annual report on Form 20-F, which is available on the SEC’s
website at www. sec.gov, for a discussion of certain of these
factors. Any forward-looking statement is based on information
available to Smith+Nephew as of the date of the statement. All
written or oral forward-looking statements attributable to
Smith+Nephew are qualified by this caution. Smith+Nephew does not
undertake any obligation to update or revise any forward-looking
statement to reflect any change in circumstances or in
Smith+Nephew's expectations.
◊ Trademark of Smith+Nephew. Certain marks registered in US
Patent and Trademark Office.
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