A medical device product and process breakthrough in rotator cuff surgery


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Aevumed is currently on a mission to advance the treatment of patients with rotator cuff tears. The PHANTOM™ suture anchor for rotator cuff repair has been cleared by the FDA for marketing and launched in March 2019. The PHANTOM-X™ is a disruptive technology under development and addresses the 20% failure rate of rotator cuff surgeries by providing both the biomechanical support and biological enhancement planned to launch in 2021.

The rotator cuff is a bundle of muscles and tendons that hold the humeral head (the ball of the shoulder) into the glenoid (the cup of the shoulder), and allow the upper arm to mobilize.  Through aging and wear, these tendons can tear away from the bone, causing pain and mobility issues.  Rotator cuff surgery aims at re-attaching these tendons to the bone. Surgeons use suture anchors to reattach the tendon back to bone. The anchor is fix to the bone through a screw or push-in mechanism and the suture ends that are attached to the anchor are threaded through the tendon to pull the tendon down to the bone. The sutures are then tightened against the tendon that presses against the bone and a knot is tied down to hold the tendon in a fixed position against the bone. The goal of the surgery is to hold the tendon and bone against each other in a fixed position to allow healing and fusion/attachment to occur at the bone/tendon interface. This process typically takes 3 to 6 months and is usually followed up by physical therapy.

For small tears, a Single Row of anchors may be used to repair the rotator cuff tear. However, a second row of anchors may be used in addition to the single row if the tear is relatively large. These second-row anchors are called Lateral Row anchors and typically differ from Single Row anchors by having a knotless system. The second row of anchors allow the sutures from the single row anchors to press down on top of the tendon then attach to the Lateral Row anchors on the second row. This technique provides a wider surface at the bone/tendon interface. Aevumed currently sells the PHANTOM® suture anchor used primarily as the single row for both small and large tears. The PHANTOM® suture anchor may be used with Lateral Row anchors and provides superior anchor fixation to bone, a unique feature that is beneficial to all patients, especially those with low bone quality.

Today, rotator cuff retears after initial surgery are the major complication accounting (20%-90%) of cases and costing over $0.5B per year.  Tear size is the best intraoperative predictor of repair integrity after rotator cuff repair, with tears less than 2 cm twice as likely to heal than tears greater than 6 cm. This problem is caused by; (1) Unavailability of biological devices that promote healing between tendon & bone; (2) High stresses induced by current implants; and (3) relatively small surface area interface between tendon & bone. Today’s solution includes using Lateral Row anchors; however, today’s available Lateral Row anchors do not provide adequate anchor to bone fixation while providing sufficient suture tension to effectively press tendon to bone.  

The magic lies in our proprietary suture anchor device called the PHANTOM™, which gives surgeons a variety of intra-operative options when performing arthroscopic rotator cuff repair.  This cost-saving anchor device carries three sutures, reduces the surgical steps from 8 to 4, and utilizes Micro-Thread on its surface - a unique micro-structure technology that aids in pull-out strength by more than 260% than tradition anchors on the market.  

The PHANTOM™ also:

Aevumed is developing the PHANTOM-L™, a unique Lateral Row anchor that tackles large tears by providing superior bone fixation using Aevumed’s proprietary MicroThread™ technology and a suture retention feature. In addition, Aevumed is also currently developing the PHANTOM-X™, a biologic delivery system that; (1) provides adequate tendon and bone attachment; (2) reduces stress over tendon; (3) and provides wide mechanical attachment to reduce the current (20%-90%) retear rates. For large tears, surgeons would be able to use all three products from Aevumed, the PHANTOM® (Single Row), PHANTOM-L™ (Lateral Row), and PHANTOM-X™ (Biologic Augmentation) to tackle large tears and reduce the retear rate. These products integrate well within the surgeon work flow and are much easier and faster than current solutions on the market with minimum training. When all three products are used, the PHANTOM-X™ (Biologic Augmentation) is used first to support and prepare the tendon before attaching it to bone. Finally, the PHANTOM® (Single Row) PHANTOM-L™ (Lateral Row) will be implanted in sequence with quantities determined by the surgeon depending on the size and the shape of the rotator cuff tear.

Orthopedic surgeons are the main drivers for selecting implants for repairing rotator cuff tears. They typically use suture anchor implants for the repair and deliver them arthroscopically, a minimally invasive technique that uses a scope, while the patient is under anesthesia.  The RIO for patients is the reduced risk of retear and surgery which means a quick recovery to their daily lives. For surgeons, the RIO is the ease of use and the reduced patient complications and dissatisfaction with their practice. Finally, there is a considerable RIO for insurance companies that advocate the Aevumed technologies because of the significant reduction in cost related to a reduction in the rate of patient reoperation. 

Aevumed PHANTOM™ Instrument Set

PHANTOM™ Instruments include Awls and Taps for different implant sizes

Aevumed PHANTOM™ Shelf Box and Labeling

Aevumed PHANTOM™ sterile package

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