New Products February 2022

Could A Newer MIS System Have An Impact For Hallux Valgus Procedures?

The CoLink Vallux^™ Active Bunion Procedure is a joint-sparing MIS option for triplanar correction of hallux valgus, according to the manufacturer, In2Bones USA. The CoLink Vallux carries an indication for fixation of translational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. The CoLink Vallux plate is a zero-prominence implant which features 30 degrees of variable angle locking technology to assist with angular stability and polyaxial screw placement. According to the company website, multiple sizes of screws are available for this system including: 2.7 mm CoLink VAL^™ variable angle locking screws; and 2.4 and 2.7 mm locking and non-locking screws.

The system includes a sterile disposable instrument kit, along with a non-sterile disposable olive wire option. In2Bones recommends using a long and narrow blade with a minimum length of 25 mm, as a saw blade is not included in the system. The reusable instrumentation set includes a variety of key components including drill guides, a plate bending iron, threaded bending bars and pointed/serrated reduction forceps.

Contraindications for the CoLink Vallux system include: bone and soft tissue compromised by disease; infection or prior implantation that cannot provide adequate support to the prosthesis; skeletal immaturity; known allergy to metal; diabetes; or active joint infection. 

Company: In2Bones USA

Product: CoLink Vallux Active Bunion Procedure

For more info, visit www.i2b-usa.com .

Might An Innovative Brace Advance Options For Offloading?

Foot Defender^™ is a protective, ambulatory brace designed to decrease the forces that walking and standing exert on the foot and ankle. According to the company, Defender Operations, the brace provides offloading to the foot that may assist in cases of wound healing and/or management of stable foot and ankle fractures.

Defender Operations shares that the Foot Defender came about as a result of a combination of biomechanical engineering, modern footwear design, and patented manufacturing techniques. They add that state-of-the-art textiles, advanced engineering, and proprietary materials for force reduction and impact attenuation, allow the product to provide an enhanced protective environment for the foot and ankle. According to a company statement, “the Foot Defender is the easy to use, stylish device that people want to wear.”

The device has an available removable cast extension and shoe-like design, contributing to a patient-friendly focus. According to the company website, they state that Foot Defender may result in less average maximum pressures compared to some CAM walker and protective boot models. The Foot Defender is assigned a HCPCS code of L4361. 

Company: Defender Operations

Product: Foot Defender

For more info, visit www.DefenderOps.com .

Postsurgical Analgesic Gains Expanded Indication For Use

Heron Therapeutics recently announced US Food and Drug Administration (FDA) expansion of the indications for ZYNRELEF^® (bupivacaine and meloxicam) extended-release solution. Now, ZYNRELEF carries an indication for soft tissue or periarticular instillation in adults in order to achieve postsurgical analgesia for up to 72 hours after foot and ankle surgeries, lower extremity total joint arthroplasty, and small-to-medium open abdominal procedures. This is a broader indication than previously approved, which included bunionectomy, open inguinal herniorraphy and total knee arthroplasty.

In a company statement, Heron Therapeutics shares that ZYNRELEF is the first and only dual-acting local anesthetic (DALA) delivering a fixed-dose combination of a local anesthetic (bupivacaine) and low dose of a non-steroid anti-inflammatory drug (meloxicam). They also state that is the first modified-release anesthetic that the FDA classified as “extended-release,” as Phase 3 studies revealed reduced pain and reduced opioid requirements during the first 72 hours following surgery compared to bupivacaine solution alone.

The company estimates that this expanded indication will cover seven million procedures annually, and hopefully allow surgeons to prevent opioid misuse. Heron shares that they continue to study ZYNRELEF in additional procedure settings. 

Company: Heron Therapeutics
Product: ZYNRELEF
For more info, visit www.ZYNRELEF.com