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

  1. 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.
  2. 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
  3. Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem: Synergy.
     Internal Report. 10143364 REV A
  4. Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem: POLARSTEM.
     Internal Report. 10143423 REV A
  5. Smith + Nephew 2024 CATALYSTEM Summary of Global Evaluations. Internal
     Report. 10143591
  6. 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
  7. Smith + Nephew 2024. Finite Element Analysis of the CATALYSTEM Hip Stem
     Design. Internal Report. OR-24-025
  8. Smith + Nephew 2024. Surgeon Feedback on the CATALYSTEM Total Hip System.
     Internal Report.  CSD.REC.24.001
  9. Smith + Nephew 2024. Cadaveric study of the repeatability of CATALYSTEM
     broach and femoral stem seating level. Internal Report. 10144794

10. 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
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