Becker's ASC Review

39 Executive Briefing Cement selection Cement quality is paramount. Heraeus Medical pioneered the PALACOS® R bone cement 50 years ago and since then developed a portfolio of different viscosities as well as gentamicin loaded cements. During those five decades, PALACOS® has earned a reputation as the gold standard cement for arthroplasty, delivering consistency, predictable outcomes and low revision rates. PALACOS® has been proven in 30 million procedures worldwide 9 and is the industry's most extensively studied bone cement. 10 In a review of 38,694 patients in the IBM Watson Marketscan database, PALACOS® bone cement had a 33 percent lower rate of joint reoperation (0.277 percent vs. 0.417 percent, p = 0.027) and a 53 percent lower rate of all cause revisions (0.08 percent vs. 0.20 percent, p=0.03) within 90 days of index procedure compared to other bone cements. PALACOS® was also associated with 0.6 percent less all-cause readmissions over 90 days (6.6 percent vs. 7.2 percent, p = 0.037). 11 Heraeus Medical is the only source for the full family of PALACOS® Bone Cements. Modern cementing techniques Modern cementing technique is the combination of thoroughly preparing the bone bed with pulsatile lavage, using vacuum mixing to strengthen the mechanical properties of the cement, and using pressurization to enable better interdigitation of cement in the bone. Pulsatile lavage removes debris to improve the cement penetration into cancellous bone structures. 12 Vacuum mixing significantly enhances the cement's mechanical strength by reducing macro- and micro-porosity. 13 This air- induced porosity leads to a rapid propagation of fractures and weakens the cement mantle. A fractured and fragile cement mantle compromises the integrity of the bone-cement and cement-implant interfaces and therefore the survivorship of the implant. 14 Heraeus Medical recently introduced PALACOS® pro, an all-in-one fixation system, which combines the gold standard PALACOS® R bone cement with vacuum mixing in one stock keeping unit. This new approach simplifies the preparation of high quality cement by requiring fewer preparatory steps. The completely closed vacuum system minimizes the risk of bone cement contamination with safe, contactless handling. Lastly, PALACOS® pro simplifies inventory management and may be fully reimbursable as an implantable depending on the ASC's contracting. With the challenges ASCs face in sterilizing instruments, one- time use pulsatile lavage systems and cement application guns can enable better on demand supply of instruments and value. Heraeus Medical is committed to bringing innovation to this space to help our ASC partners. Takeaways Enormous growth is projected for total joint arthroplasty and related procedures in the U.S. As demand grows, ASCs will be an attractive option for certain patient populations, if they can minimize postoperative complications and revisions. While not a silver bullet, cement and proper cementing technique plays an important role in realizing cost-effective care. Based on insights and clinical experience gleaned from our customers, Heraeus Medical offers these best practices: • Carefully evaluate patient populations to select only those who are best-suited for same-day outpatient arthroplasty procedures. • Review pathways for managing outpatient joints published by Dr. Berger and others to identify ways to bring greater standardization, safety and simplification to critical processes. • Collect and analyze data at your center to understand the value that cement and modern cementing technique can bring to your operations. • Implement rigorous training and continuing education for the entire surgical team based on these policies. Heraeus Medical known as a global leader in joint fixation and infection management in orthopedics and trauma surgery. This enables the company to make an important contribution to supporting surgeons and the surgical team and to improve surgery outcomes. In the area of biomaterials, Heraeus Medical focuses on products for use in bone and joint surgery. The core product PALACOS® is considered the gold standard among bone cements and has repeatedly proven itself over five decades of clinical use. 9 Heraeus medical data on file. 10 Pilz V, Hanstein T. A Literature Review of the Clinical Evidence Situation of Bone Cements. Journal of Medical and Health Sciences. 2018;1:31-36. 11 Manuscript in preparation. Data on file. 12 Schlegel U, Siewe J, Delank K, Eysel P, Puschel K, Morlock M, Gerbert de Uhlenbrock A (2010) Pulsed Lavage Improves Fixation Strength of Cemented Tibial Components. International Orthopedics, October 16, 2010. 13 Malchau H, Herberts P (2000) Prognosis of total hip replacement. 65th Annual Meeting of the AAOS. March 12-19, Orlando, USA 14 Wang, Jian-Sheng. (2005) The Well-Cemented Total Hip Arthroplasty (Breusch, Steffen and Malchau, Henrik). Springer, Berlin, Heidelberg, 4.1 pp 108-109¬

• Cover