Enovis™ Releases AltiVate Reverse® Glenoid System, Widening Range of Patients Who May be Treated with AltiVate Reverse®
Enovis™ (NYSE: ENOV) has launched the AltiVate Reverse® Glenoid System, enhancing its market-leading AltiVate Reverse line. This new system, which received FDA 510(k) clearance in May 2024, offers modular, augmented baseplates and bone-sparing options, aiming to broaden the range of patients suitable for reverse shoulder arthroplasty. The first surgery using this system was performed by Dr. Mark Frankle at Tampa General Hospital on July 8, 2024. The system includes neutral and 15° wedge options, various central compression screw lengths, and four new glenospheres to optimize patient outcomes. Reverse shoulder arthroplasty accounts for over 60% of the 200,000+ annual shoulder replacements in the U.S., highlighting the growing demand for versatile implants. Enovis continues to prioritize surgeon-driven innovation and patient care through its comprehensive and efficient solutions.
- FDA 510(k) clearance received in May 2024.
- Introduction of modular, augmented baseplates.
- Bone-sparing baseplate design.
- First clinical use by leading surgeon Dr. Mark Frankle.
- Four new glenospheres added to the RSP® offering.
- None.
Insights
The introduction of the AltiVate Reverse® Glenoid System by Enovis represents a significant advancement in the field of shoulder arthroplasty. The system's modular baseplate options, including neutral and 15° wedge options, provide surgeons with the flexibility to optimize the implant for each patient's unique anatomical needs. This is particularly important in reverse shoulder arthroplasty, which involves reversing the ball-and-socket configuration of the shoulder joint. This procedure is often performed on patients with severe rotator cuff damage or other complex shoulder issues, making the ability to customize the implant a notable innovation.
The bone-sparing design of the baseplate, which aims to preserve the glenoid vault, is another critical feature. Preserving bone is essential in shoulder arthroplasty as it can lead to better long-term outcomes and fewer complications down the line. The new glenosphere options also add to the versatility of the system, allowing for better biomechanical alignment and potentially increasing the longevity of the implant.
Overall, this new system could significantly improve patient outcomes by providing more tailored solutions for complex shoulder conditions. The fact that it has already received FDA 510(k) clearance further validates its clinical potential.
Enovis' introduction of the AltiVate Reverse® Glenoid System is likely to have a positive impact on its financial performance. The new system expands the company's already robust portfolio in the shoulder arthroplasty market, which is growing steadily. According to industry data, reverse shoulder arthroplasty accounts for over 60% of the more than 200,000 shoulder replacements performed annually in the United States. This indicates a substantial market opportunity.
The FDA 510(k) clearance is a significant milestone, as it allows the company to market and sell the product immediately. This clearance can be seen as a vote of confidence in the product's safety and efficacy, which could drive adoption among surgeons and healthcare facilities.
Furthermore, the use of this system in a real-world surgical setting by a renowned shoulder surgeon like Dr. Mark Frankle adds credibility and may accelerate market acceptance. From a financial perspective, the new system's modularity and efficiency could also lead to cost savings for healthcare providers, making it an attractive option in a cost-conscious medical environment.
New full-range solution adds bone-sparing baseplate, peripheral fixation, and glenosphere options to proven reverse shoulder prosthesis (RSP®) glenoid baseplate while maintaining hallmark simplicity and efficiency. First surgery using AltiVate Reverse® Glenoid System conducted by Dr. Mark Frankle at Tampa General Hospital on Monday, July 8, 2024.
AUSTIN, TX, July 12, 2024 (GLOBE NEWSWIRE) -- Enovis™ (NYSE: ENOV), a leading innovator in shoulder arthroplasty systems that help improve quality of life and restore movement, introduced today the one-tray AltiVate Reverse® Glenoid System, which expands the glenoid implant offering of the market-leading AltiVate Reverse to include modular, augmented baseplates. Based on the Company’s central screw fixation design with a minimum of 10 years of clinical follow-up1, the AltiVate Reverse® Glenoid System received FDA 510(k) clearance in May 2024 for use in reverse shoulder arthroplasty, including revisions, making it an important addition to Enovis’ industry-leading AltiVate® products.
“We are very pleased to offer a modular, augmented baseplate based on the proven central screw fixation principle of our legacy Reverse Shoulder Prosthesis (RSP®) system2,” said Louie Vogt, Group President of Enovis™ Reconstructive Business Group. “This addition to our market-leading AltiVate Reverse continues our long history of surgeon-driven innovation and commitment to exceptional patient outcomes.”
The AltiVate Reverse® Glenoid System offers a modular baseplate with neutral and 15° wedge options, as well as multiple central compression screw lengths and diameters. The baseplate boss was designed to be more bone-sparing than any other currently available baseplate with a comparable central through-screw design to minimize the volume of bone removed and preserve the glenoid vault. It also adds four new glenospheres to the already robust RSP® offering, giving surgeons a comprehensive selection to optimize the biomechanical needs of each individual patient and maximize implant longevity2,3.
Reverse shoulder arthroplasty represents over 60 percent of the more than 200,000 shoulder replacements performed annually in the United States4. In a reverse shoulder replacement, the position of the ball and socket are switched. Developed in the 1980s in Europe and approved by the FDA in 2003, indications for this procedure continue to expand, increasing the demand for implants that can be used in a variety of patients.
The first surgery using AltiVate Reverse® Glenoid was conducted by Dr. Mark Frankle at Tampa General Hospital on Monday, July 8. Dr. Frankle is an international leader in shoulder surgery and has been performing reverse shoulder replacements for over two decades.
“The new AltiVate Reverse® Glenoid is a major innovation for my practice,” says Dr. Frankle. “I now have one system with a variety of options to treat most, if not all, of my patients. It is simple and efficient while still offering the fixation and implant options I need, and it’s very exciting to be the first to use it clinically.”
For more information about AltiVate Reverse® Glenoid System, please visit https://enovis.com/our-brands/surgical/altivate-reverse-glenoid.
References
1,2 Cuff, et al. “Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency: a concise follow-up, at a minimum of 10 years, of previous reports.” Journal of Bone and Joint Surgery. 2017.
3 Levin, et al. “Optimizing Muscle-Tendon Lengths in Reverse Total Shoulder Arthroplasty: Evaluation of Surgical and Implant-Design-Related Parameters.” Journal of Bone and Joint Surgery. 2024.
4 SmartTRAK®, https://app.smarttrak.com/markets/qs/32f3e3a89d794cbcac10027375315668
Dr. Frankle is a paid consultant of Enovis.
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. The Company’s shares of common stock are listed in the United States on the New York Stock Exchange under the symbol ENOV. For more information about Enovis, please visit www.enovis.com.
Media Contact
Kristen McColpin
Director of Marketing Communications, Enovis Surgical
kristen.mccolpin@enovis.com
FAQ
What is the Enovis AltiVate Reverse® Glenoid System?
When did the AltiVate Reverse® Glenoid System receive FDA clearance?
Who performed the first surgery using the AltiVate Reverse® Glenoid System?
What are the new features of the AltiVate Reverse® Glenoid System?
How does the AltiVate Reverse® Glenoid System benefit patients?
