Enovis™ Introduces STAR® Ankle, now with e+™ Polyethylene for Unmatched Durability

Rhea-AI Summary

Enovis (NYSE: ENOV) has introduced the STAR® Ankle with new e+™ Polyethylene, following FDA approval. This makes it the first and only mobile bearing ankle system with e+™ Polyethylene in the United States. The implant's vitamin E-blended insert offers improved durability, stability, and longevity.

Key features of e+™ Polyethylene include:

• Resistance to oxidation
• Consistent wear rates
• Stable mechanical properties over time

The STAR® Ankle has been used globally over 40,000 times across its 37-year history. This innovation, combined with the recent release of STAR Patient Specific Instrumentation (PSI), represents Enovis' commitment to enhancing patient satisfaction and outcomes in foot and ankle solutions.

Positive

• First and only mobile bearing ankle system with e+™ Polyethylene in the US
• Improved durability, stability, and longevity of the implant
• Resistance to oxidation and consistent wear rates of e+™ Polyethylene
• STAR® Ankle has been used globally over 40,000 times in 37 years
• Recent release of STAR Patient Specific Instrumentation (PSI) enhancing patient outcomes

Negative

• None.

Medical Research Analyst

The introduction of e+™ Polyethylene in the STAR® Ankle system represents a significant advancement in ankle replacement technology. The vitamin E-blended insert offers improved durability and oxidative resistance, potentially leading to longer-lasting implants and better patient outcomes.

Key points to consider:

• First mobile bearing ankle system with e+™ Polyethylene in the US
• Maintains consistent wear rates and stable mechanical properties over time
• Avoids the 12% reduction in mechanical strength seen in remelted polyethylenes

While this innovation is promising, long-term clinical studies will be important to confirm the expected benefits in real-world patient outcomes. Investors should monitor future clinical data to assess the true impact on Enovis' market position in the ankle replacement sector.

Financial Analyst

This product enhancement could potentially strengthen Enovis' position in the competitive orthopedic implant market. Key financial implications include:

• Potential for increased market share in the ankle replacement segment
• Possible higher profit margins if the improved technology commands a premium price
• Opportunity for expanded revenue streams through upgrades for existing STAR® Ankle users

However, it's important to note that the impact on Enovis' financials may take time to materialize. Investors should closely monitor upcoming quarterly reports for indicators of revenue growth and market adoption rates in the foot and ankle division. The company's ability to leverage this innovation for sustained competitive advantage will be important for long-term value creation.

Revolutionary Scandinavian Total Ankle Replacement (STAR® Ankle) System Now Includes Vitamin E-Blended Polyethylene Insert

Wilmington, DE, Aug. 19, 2024 (GLOBE NEWSWIRE) --  Enovis™ Corporation (NYSE: ENOV), an innovation-driven medical technology company, proudly unveils its Scandinavian Total Ankle Replacement (STAR^® Ankle), now with new e+™ Polyethylene. Recent U.S. Food and Drug Administration (FDA) approval makes STAR^® Ankle the first and only mobile bearing ankle system with e+™ Polyethylene in the United States.¹ The implant’s new vitamin E-blended e+™ Polyethylene insert will offer improved durability, stability, and longevity.¹

"With e+™ Polyethylene, we uphold our commitment to the advancement of our total ankle portfolio, merging full oxidative resistance with the time-tested design of the STAR^® Ankle,” said Gary Justak, President and General Manager of Enovis Foot & Ankle. “Building upon the proven success of the STAR^® Ankle epitomizes our culture of advancing foot and ankle solutions and elevating patient treatment options. We don't just set the standard—we redefine it.”

e+™ Polyethylene contains the free radical-neutralizing antioxidant vitamin E; as a result, the material resists oxidation and maintains consistent wear rates and stable mechanical properties over time. In contrast, other highly crosslinked polyethylenes are remelted during manufacturing to neutralize free radicals², a process that can reduce their mechanical strength by up to 12%.^1,3

“After extensive clinical experience with this superior material in knee and shoulder implants, along with years of laboratory testing, I expect improved patient outcomes through increased polyethylene longevity. This builds on the outstanding STAR^® Ankle long-term metal-component survival rates seen in multiple clinical studies,” stated Dr. Gregory Lundeen, a foot and ankle orthopedic surgeon at Reno Orthopedic Center.

Combined with the recent release of STAR Patient Specific Instrumentation (PSI), the STAR+ Experience represents Enovis’ commitment to continuous improvement, aimed at enhancing patient satisfaction and outcomes. The integration of e+™ Polyethylene in the STAR^® Ankle continues to enhance the remarkable success of this implant, which has been used globally over 40,000 times across its 37-year history.⁴

For more information about the STAR^® Ankle with e+™ Polyethylene and Enovis' innovative foot and ankle solutions, please visit https://www.enovis.com/products/star-ankle.

Individual results may vary. Neither Enovis™ Corporation nor any of its subsidiaries dispense medical advice. The contents of this release do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

Dr. Gregory Lundeen is a consultant for Enovis™ Corporation.

References

1. e+ testing data on file. Bench test results not necessarily indicative of clinical performance.
2. Jennings et al. The influence of femoral condylar lift-off on the wear of artificial knee joints. Proc Inst Mech Eng [H]. 2007 Apr;221(3):305-14.
3. S.M. Kurtz. “The UHMWPE Handbook: Ultra-high Molecular Weight Polyethylene in Total Joint Replacement”. Elsevier Academic Press, 2009.
4. Enovis^® internal document: Includes world-wide implantations of all generations; newest generation has over 40,000 world-wide from 1998-2022

About Enovis

Enovis™ Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

Media Contact

Diana Aldermae

Enovis Foot & Ankle

Diana.Aldermae@enovis.com

MK-10554

Attachment

• STAR® Ankle with e+™ Polyethylene

FAQ

What is the new feature of the STAR® Ankle introduced by Enovis (ENOV)?

Enovis has introduced the STAR® Ankle with new e+™ Polyethylene, a vitamin E-blended insert that offers improved durability, stability, and longevity.

How does the e+™ Polyethylene in STAR® Ankle differ from other polyethylenes?

e+™ Polyethylene contains vitamin E, which resists oxidation and maintains consistent wear rates and stable mechanical properties over time, unlike other highly crosslinked polyethylenes that may lose mechanical strength during manufacturing.

What is the clinical history of the STAR® Ankle system?

The STAR® Ankle system has been used globally over 40,000 times across its 37-year history, demonstrating a long-standing track record in ankle replacement procedures.

What recent innovations has Enovis (ENOV) introduced for the STAR® Ankle system?

In addition to the e+™ Polyethylene, Enovis has recently released STAR Patient Specific Instrumentation (PSI), aimed at enhancing patient satisfaction and outcomes in foot and ankle solutions.