SOURCE: Aesculap

Aesculap

October 17, 2014 11:48 ET

Aesculap Implant Systems Announces Launch of Plasmafit™ Pro Acetabular System With Vitelene™ Liner

Plasmafit Pro System Provides High Stability and Performance When Used in Conjunction With a Prosthetic Femoral Head and Hip Stem as Treatment for Total Hip Arthroplasty

CENTER VALLEY, PA--(Marketwired - October 17, 2014) - Aesculap Implant Systems announced today the launch of the Plasmafit™ Pro Acetabular System with the Vitelene™ liner. The Plasmafit Pro two-piece system consists of a cementless titanium acetabular shell and a highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) vitamin E blended liner. The hemispherical and slightly flattened design of the Plasmafit Pro cup along with a rough titanium plasma spray on the outer surface provides a high level of stability for strong primary and long-term implant fixation. The Vitelene liner is formulated with antioxidant protection that provides excellent wear and oxidation resistance and balanced mechanical properties1.

The cup design of the Plasmafit Pro acetabular system features a modified dome shape for exceptional anchoring, providing immediate grip-feel during implantation. The equatorial pressfit design grabs the rim of the acetabulum, reducing the potential for mal-alignment and minimizing the chance of movement once seated in the socket. The internal design of the Plasmafit Pro cup includes a taper locking mechanism to stabilize the liner for a precise fit on the liner within the cup. The secure fixation of the liner facilitates high stability against tilting and rotation forces.

The Plasmafit Pro cup is coated with a titanium porous plasma spray that provides an enhanced surface to help prevent migration of the implant and supports high primary stability. The plasma spray is designed to allow biologic fixation between the bone and prosthesis for long-term survivorship.

The Vitelene liner prevents oxidation and degradation of polyethylene and maintains mechanical properties after accelerated age testing. Vitamin E increases the resistance of polyethylene against oxidative processes and strengthens the bearing material throughout the lifespan of the total hip arthroplasty. Vitelene displayed no measurable oxidation compared to conventional UHMWPE, which displayed significant oxidation, during accelerated age testing per ASTM F20032. Accelerated age tests show an 89% reduction in wear for the Vitelene liners when compared to conventional polyethylene liners3.

The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended to replace a hip joint. The device is intended for patients suffering from severe hip pain and disability due to arthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. For complete indications, contraindications, warnings and precautions visit aesculapimplantsystems.com.

Feel the fit of the Plasmafit Pro Acetabular System. Visit: aesculapimplantsystems.com/Plasmafit.

1Performance after accelerated aging per ASTM F2003. Bench testing is not necessarily indicative of clinical performance. Data on file.

2Both, conventional UHMWPE (radiation sterilized Chirulen® 1020) and Vitelene™ were accelerated aged one (1), two (2) and three (3) cycles according to ASTM F2003 and were tested for oxidation index (OI) according to ASTM F2102. The accelerated aging cycle according to ASTM F2003 is an aging method where samples are subjected to 100% oxygen, 84 psi, and 70ºC for two weeks. The oxidation indices for Vitelene™ are below 0.1 (no detectable oxidation) after all aging cycles. Even after 3 cycles, Vitelene™ exhibits an oxidation index of 0.05. In contrast, after 2 weeks of aging, the conventional UHMWPE (radiation sterilized Chirulen® 1020) samples showed detectable oxidation with an OI of about 0.6. After two (2) cycles (28 days) an averaged oxidation index greater than four (4) was detected. Due to the high degree of oxidation and the accompanied brittleness, conventional UHMWPE was unable to analyze after 3 cycles (42 days) accelerated aging. Therefore, it can be concluded that Vitelene™ resists long term exposure to an oxidative environment and shows no aging effects nor material induced failure. Bench testing is not necessarily indicative of clinical performance.

3Data on file. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

About Aesculap Implant Systems, LLC
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

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