Charles Sternberg, Associate Editor09.19.22
Anika Therapeutics Inc., a global joint preservation company focused on early intervention orthopedics, has announced the limited market release and the first surgeries performed using the X-Twist Fixation System. Christopher E. Baker, M.D., a prominent sports medicine physician in Tampa, Florida, was the first surgeon to use the X-Twist Fixation System.
“The X-Twist is a new addition to the Anika sports medicine portfolio that brings their anchor options to the highest standard in orthopedics in the market,” said Christopher E. Baker, M.D., from the Florida Orthopaedic Institute in Tampa, Florida. “The instrumentation is easy to use and intuitive, and fixation is robust. This is an anchor that can be used both knotless and as a knotted traditional anchor offering a wide spectrum of options for suture preference, including tape. In my rotator cuff repairs, this will supplement my medial row anchor in poor bone quality and will become my primary lateral row anchor. The X-Twist can easily be used for nearly any soft tissue repair within the shoulder and throughout the body.”
The feature-rich design includes venting intended to support cellular infiltration through the anchor to promote bony ingrowth; a double helix thread that allows fast and easy deployment; the ability to support the surgeon’s preferred combination of multiple sliding suture or tape configurations; and the unique X-Spline drive technology which provides more torque transfer for easy anchor insertion. In addition to the shoulder, the X-Twist Fixation System has direct applications in a variety of procedures, including the foot and ankle, and other extremities. The system will initially be available in PEEK.
In May 2022, Anika received 510(k) clearance from the FDA for the X-Twist Fixation System. The device is a cornerstone product for Anika’s sports medicine business and will address the needs of surgeons performing high volume procedures such as rotator cuff repair and ankle stabilization procedures. Within these procedures, ease of use and the convenience of an anchor that allows for multiple suture and tape configurations is highly desirable, especially in the ambulatory surgery center (ASC), where the majority of these cases are performed.
“The release of the X-Twist Fixation System is the first of several Anika products to launch in the U.S. in 2022 and 2023 in the sports medicine, implant, and regenerative markets. This launch demonstrates Anika’s commitment and ability to develop, market, and commercialize products within our expanded $8 billion global market including joint preservation and restoration, and especially in the shoulder repair market, which is integral to our growth strategy,” said Cheryl R. Blanchard, Ph.D., Anika’s president and CEO. “Anika’s Sports Medicine team, comprised of industry leaders, is building momentum through this launch and with our recent hardware augmentation indication for Tactoset, this momentum will only increase as we execute on our joint preservation strategy.”
In addition to being a meaningful advancement in features and performance for surgeons, this new suture anchor family provides further reach for Anika’s Tactoset Injectable Bone Substitute. Tactoset’s indications for use include augmentation of hardware, such as suture anchors, and is an ideal option for rotator cuff repair in poor bone quality where improved suture anchor fixation is desired. The strength of Anika’s growing family of rotator cuff solutions bolsters its competitiveness and market attractiveness in this key area of clinical and patient need and sets the stage for additional new product launches into 2023 and beyond.
Anika is initially offering the X-Twist Fixation System in the U.S. through a limited market release, with a full market release expected into 2023. Anika expects to introduce the X-Twist Fixation System internationally in select markets at the time of full market release.
Reference:
1 Data on file.
“The X-Twist is a new addition to the Anika sports medicine portfolio that brings their anchor options to the highest standard in orthopedics in the market,” said Christopher E. Baker, M.D., from the Florida Orthopaedic Institute in Tampa, Florida. “The instrumentation is easy to use and intuitive, and fixation is robust. This is an anchor that can be used both knotless and as a knotted traditional anchor offering a wide spectrum of options for suture preference, including tape. In my rotator cuff repairs, this will supplement my medial row anchor in poor bone quality and will become my primary lateral row anchor. The X-Twist can easily be used for nearly any soft tissue repair within the shoulder and throughout the body.”
About the X-Twist Fixation System
The X-Twist Fixation System is a platform of suture anchors designed to be mechanically strong1, easy to use, and support healing for cases such as rotator cuff repair. The system affords surgeons a variety of knotless and knotted soft tissue fixation options in a single anchor platform.The feature-rich design includes venting intended to support cellular infiltration through the anchor to promote bony ingrowth; a double helix thread that allows fast and easy deployment; the ability to support the surgeon’s preferred combination of multiple sliding suture or tape configurations; and the unique X-Spline drive technology which provides more torque transfer for easy anchor insertion. In addition to the shoulder, the X-Twist Fixation System has direct applications in a variety of procedures, including the foot and ankle, and other extremities. The system will initially be available in PEEK.
In May 2022, Anika received 510(k) clearance from the FDA for the X-Twist Fixation System. The device is a cornerstone product for Anika’s sports medicine business and will address the needs of surgeons performing high volume procedures such as rotator cuff repair and ankle stabilization procedures. Within these procedures, ease of use and the convenience of an anchor that allows for multiple suture and tape configurations is highly desirable, especially in the ambulatory surgery center (ASC), where the majority of these cases are performed.
“The release of the X-Twist Fixation System is the first of several Anika products to launch in the U.S. in 2022 and 2023 in the sports medicine, implant, and regenerative markets. This launch demonstrates Anika’s commitment and ability to develop, market, and commercialize products within our expanded $8 billion global market including joint preservation and restoration, and especially in the shoulder repair market, which is integral to our growth strategy,” said Cheryl R. Blanchard, Ph.D., Anika’s president and CEO. “Anika’s Sports Medicine team, comprised of industry leaders, is building momentum through this launch and with our recent hardware augmentation indication for Tactoset, this momentum will only increase as we execute on our joint preservation strategy.”
In addition to being a meaningful advancement in features and performance for surgeons, this new suture anchor family provides further reach for Anika’s Tactoset Injectable Bone Substitute. Tactoset’s indications for use include augmentation of hardware, such as suture anchors, and is an ideal option for rotator cuff repair in poor bone quality where improved suture anchor fixation is desired. The strength of Anika’s growing family of rotator cuff solutions bolsters its competitiveness and market attractiveness in this key area of clinical and patient need and sets the stage for additional new product launches into 2023 and beyond.
Anika is initially offering the X-Twist Fixation System in the U.S. through a limited market release, with a full market release expected into 2023. Anika expects to introduce the X-Twist Fixation System internationally in select markets at the time of full market release.
Reference:
1 Data on file.
