REGENETEN Rotator cuff Bioinductive Implant for Rotator Cuff Repair | Smith & Nephew - US Professional
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REGENETEN

Bioinductive Implant

REGENETEN Rotator Cuff Implant Image

Overview

REGENETEN Bioinductive Implant
Changing the course of rotator cuff repair

Rotator cuff disease is a significant and costly problem2-4 that causes ongoing pain and limits patients’ mobility.5 Progressive in nature, small tears tend to grow in size and severity over time, eventually requiring surgery.1-3

  • Up to 80% of partial-thickness tears increase in size within 2 years6
  • Untreated rotator cuff tendinosis can progress to a partial - or full-thickness tear7
  • Larger tears requiring surgery tend to re-tear over 40% of the time8-10

 

REGENETEN Bioinductive Implant
Now you can disrupt rotator cuff disease progression biologically1

The REGENETEN Bioinductive Implant stimulates the body’s natural healing response to support new tendon growth and disrupt disease progression.1,2 Derived from highly purified bovine Achilles tendon, it creates an environment that is conducive to healing.1,2

Biologically improve healing

  • Proprietary, highly porous implant design facilitates the formation of new tendon-like tissue1,2
  • New tissue reduces the peak strain at the site of the tear11
  • Gradually absorbs within 6 months and leaves a layer of new tendon-like tissue to biologically augment the existing tendon 12



Proven Results, Positive Outcomes 1*

Demonstrated clinical efficacy 1

  • Induction of new tendon-like tissue in all patients (N=33)
  • Mean increase of tendon thickness of 2.2 mm (P < 0.0001) at 3 months
  • Reduction in defect size of at least 1 grade†

Excellent safety profile1

  • No foreign body/inflammatory reaction
  • No implant-related complications

Impressive patient outcomes1

  • High patient satisfaction (94%) after 1 year
  • Rapid recovery: average 23 days of sling time
  • Significantly improved ASES pain score at 1 year (P < 0.0001)‡

For distribution in the US and its territories only

*Results from a prospective multi-center study of patients with partial-thickness tears. Patients had chronic, degenerative, intermediate grade (n=12) or high grade (n=21) partial-thickness tears of the supraspinatus tendon. The REGENETEN Bioinductive Implant was attached following arthroscopic subacromial decompression without repair. Clinical outcomes were assessed pre-op and at 3 and 12 months post-op using American Shoulder and Elbow Surgeons (ASES) and Constant-Murley (CM) scores. Post-op tendon healing and thickness was assessed with MRI.

†In 31 (94%) patients over 12 months.

‡ASES pain score improved from 4.2 ± 0.4 standard error of mean (SEM) at baseline to 0.6 ± 0.2 (SEM) at 1 year.

 

References
1. Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2017. doi: http://dx.doi.org/10.1016/j.jse.2017.08.023.
2. Bokor DJ, Sonnabend D, Deady L et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. MLTJ. 2016;6(1):16-25.
3. Washburn R, Anderson TM, Tokish JM. Arthroscopic rotator cuff augmentation: Surgical technique using bovine collagen bioinductive implant. Arthroscopy Techniques. 2017:6(2);e297-e301.
4. Mather RC, Koenig L, Acevedo D et al. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am. 2013;95:1993-2000.
5. Lin JC, Weintraub N, Aragaki DR. Nonsurgical treatment for rotator cuff injury in the elderly. Am Med Dir Assoc. 2008;9(9):626-32. doi: 10.1016/j.jamda.2008.05.003.
6. Yamanaka K and Matsumoto T. The joint side tear of the rotator cuff: A followup study by arthrography.
Clinical Orthopaedics and Related Research. 1994: 304,68-73.
7. Keener JD, Galatz LM, Teefey SA et al. A prospective evaluation of survivorship of asymptomatic degenerative rotator cuff tears. J Bone Joint Surg Am. 2015;97:89-98.
8. Bishop J, Klepps S, Lo IK, Bird J, Gladstone JN, Flatow EL. Cuff integrity after arthroscopic versus open rotator cuff repair: A prospective study. J Shoulder Elbow Surg. 2006;15(3):290-299.
9. Heuberer PR, Smolen D, Pauzenberger L et al. Longitudinal long-term magnetic resonance imaging and clinical follow-up after single-row arthroscopic rotator cuff repair. Am J Sports Med. 2017;45(6):1283-1288.
10. Henry P, Wasserstein D, Park S, et al. Arthroscopic repair for chronic massive rotator cuff tears: A systematic review. Arthroscopy. 2015;31(12):2472-80.
11. Chen Q. Proof-of-concept finite element modelling of effect of tissue induction on rotator cuff tears. Material and Structural Testing Core, Mayo Clinic, Rochester, MN.
12. Van Kampen C, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: A histological evaluation in sheep. MLTJ. 2013;3:229-235.
13. Bokor DJ, Sonnabend D, Deady L et al. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up. MLTJ. 2015;5(3):144-150.

Ordering Information

Ordering Information
For distribution in the US and its territories only


Implants
Order #      Description
2169-3       Large Arthroscopic Bioinductive Implant (1)
2169-2       Medium Arthroscopic Bioinductive Implant (1)

Anchors
Order #      Description
2503-A      Bone Anchors (3) with Arthroscopic Delivery System
2504-1      Tendon Anchors (8)

Accessory Devices
Order #      Description
4173-1      Tendon Marker (2)
4402         Tendon Stabilizing Guide (1)
2503-S      Bone Anchor (1)

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This information is intended for health care professionals in the United States only.

Caution: US Federal law restricts the sale of these devices to or on the order of a physician.