What is REGENETEN Bioinductive Implant?
REGENETEN Bioinductive Implant is a medical device employed for the treatment of rotator cuff tears following a shoulder injury.
Standard rotator cuff repair techniques that involve stitching the rotator cuff tendon to the shoulder bone are connected with potentially lengthy rehabilitation and considerable lifestyle interruption. Consequently, many patients prefer to refrain from surgery until their pain is severe and daily routines are affected. However, the progression of rotator cuff disease can make small tears grow in severity and size over time, making surgical repair increasingly difficult for your surgeon.
The REGENETEN Bioinductive Implant is a minimally invasive, advanced healing solution that goes beyond standard surgery to help the rotator cuff tendon heal through induction or regeneration of new tendinous tissue growth across all types of rotator cuff tears. It is a bioabsorbable implant device that provides a coating of collagen over injured tendons to facilitate early healing.
Obtained from a highly purified bovine Achilles tendon, the REGENETEN Bioinductive implant is about the size of a postage stamp that creates an environment favorable for tendon healing. It induces the body’s natural healing response to support new tendon growth as well as averts the progression of rotator cuff disease, thereby helping patients with rotator cuff tears heal earlier and quicker. Consequently, many patients have been able to get back to their active lifestyles faster than ever before while lowering the prospect of further degeneration or re-tears.
Benefits of REGENETEN Bioinductive Implant
Depending on the severity of rotator cuff injury, the Bioinductive Implant can offer a range of potential benefits, including:
- Shorter rehabilitation
- Faster recovery
- Significant pain relief within few weeks
- Slowing or prevention of disease progression
- Minimal risk of subsequent degenerative tears
- Healing of partial-thickness tears
Indications for REGENETEN Bioinductive Implant
REGENETEN Bioinductive Implant is indicated for the protection and management of rotator cuff tendon injuries where there has been no considerable loss of tendon tissue. The shoulder joint is a ball and socket joint formed by the union of the head of the upper arm bone (humerus) and the shoulder socket (glenoid). A rotator cuff is a group of four tendons that join the head of the humerus to the deeper shoulder muscles to provide stability and mobility to the shoulder joint. Major injury to these tendons may result in a tear and the condition is called rotator cuff tear. It is one of the most common causes of shoulder pain in athletes, middle-aged adults, and older individuals.
Preparation for REGENETEN Bioinductive Implant
In general, pre-procedure preparation for REGENETEN Bioinductive Implant placement involves the following steps:
- A review of your medical history and a physical examination to check for any medical issues that need to be addressed prior to surgery.
- Depending on your medical history, social history, and age, you may need to undergo tests such as blood work to help detect any abnormalities that could compromise the safety of the procedure.
- You will be asked if you have allergies to medications, anesthesia, or latex.
- You should inform your doctor of any medications or supplements you are taking or any medical conditions you have such as lung or heart disease.
- You may be asked to stop taking blood-thinners, anti-inflammatories, or supplements for a week or two.
- You should refrain from alcohol and tobacco at least a few days prior to surgery and several weeks after, as it can hinder the healing process.
- You should not consume any solids or liquids at least 8 hours prior to surgery.
- Arrange for someone to drive you home as you will not be alert enough to drive yourself after surgery.
- Signed informed consent will be obtained from you after the procedure has been explained in detail.
Procedure for REGENETEN Bioinductive Implant
REGENETEN Bioinductive Implant placement procedure for rotator cuff injury is usually performed arthroscopically. This is a minimally invasive surgery performed through tiny incisions, about 1 cm each, with an arthroscope - a small fiber-optic viewing instrument with a tiny lens, light source, and a camera at its end. The surgery takes about 1-1/2 hours, and you may go home the same day. In general, the procedure involves the following steps:
- You will be administered general or regional anesthesia by your anesthesiologist.
- Two to three small keyhole incisions are made on the skin near the shoulder joint.
- An arthroscope is inserted through one of the incisions.
- The camera attached to the arthroscope displays the image of the joint on a monitor, allowing your surgeon to determine the amount of damage and type of injury present.
- Miniature surgical instruments are inserted through the other incisions to remove the damaged part of the tendon and injured surrounding tissue.
- The REGENETEN Bioinductive Implant is placed over the location of your rotator cuff tendon injury and secured in place using small anchors. The implant stimulates the formation of fresh tendinous tissue over the surface of the rotator cuff tendon, resulting in a thicker tendon.
- Your surgeon may also carry out any other repair if needed, and after adequate repair has been achieved, the scope and the instruments are withdrawn.
- The tiny incisions are then closed with stitches or small sterile bandage strips.
Postoperative Care and Recovery
In general, postoperative care instructions and recovery after REGENETEN Bioinductive Implant placement involves the following steps:
- You will be transferred to the recovery area where your nurse will closely observe you for any allergic/anesthetic reactions and monitor your vital signs as you recover.
- Following the surgery, your arm may be placed in a shoulder sling for 2 to 4 weeks to rest the shoulder and promote healing.
- You may notice some pain, swelling, and discomfort in the shoulder area. Pain and anti-inflammatory medications are provided as needed to address these.
- You may also apply ice packs on the shoulder area to help reduce swelling and pain.
- Antibiotics are also prescribed to address the risk of surgery-related infection.
- Instructions on incision site care and bathing will be provided to keep the wound clean and dry.
- Refrain from strenuous activities, lifting heavy weights, and driving for the first 6 weeks. A gradual increase in activities is recommended.
- An individualized physical therapy regimen will be designed to help strengthen your shoulder muscles and optimize shoulder function.
- You will be able to resume your normal activities in a month or two with certain activity restrictions, however, return to sports may take 4 to 6 months.
- Periodic follow-up appointments will be scheduled to monitor your progress.
Risks and Complications
REGENETEN Bioinductive Implant is a relatively safe procedure; however, as with any surgery, some risks and complications may occur, such as the following:
- Infection
- Bleeding
- Postoperative pain
- Damage to surrounding tissues
- Blood clots or deep vein thrombosis (DVT)
- Shoulder stiffness
- Anesthetic/allergic reactions
