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REGENETEN

Bioinductive Implant

REGENETEN Rotator Cuff Implant Image

Overview

Redefining healing potential in rotator cuff repair

Stimulating a natural healing response to induce new tendon-like tissue growth and disrupt rotator cuff disease progression…across the tear spectrum1-7

The REGENTEN Bioinductive Implant, comprised of type 1 collagen,8 is an advanced healing solution for biological enhancement and tendon regeneration across all rotator cuff tear types.

As a different approach to managing rotator cuff pathology, evidence has demonstrated:

  • Clinical performance in partial-thickness, large, and massive tears1-7
  • Repair strength in the induced tissue, not the implant, and completely absorbed within six months2,9
  • Increased and sustained tendon thickness, observed up to 5 years3,4,6
  • Improved patient satisfaction,4 pain,4,5 and recovery5

Backed by a growing body of clinical evidence

Also for massive tears

Read how REGENETEN resulted in high rates of tendon healing and consistent treatment success…with no adverse implant-related incidents.1

Examining tendon thickness and integrity…

Read how REGENETEN performed at 5-year follow-up, and how it improved patient pain and function.3  

For tendinous tissue formation…

Read clinical data on tissue formation, pain, and function in patients with partial-thickness tears of the supraspinatus tendon.4

On patient pain, function, and recovery…

Read how REGENETEN achieved meaningful improvements for patients with partial and full-thickness tears, and the impact on their return to driving and sport.5

View the full evidence collection here.

Simple arthroscopic delivery through a small incision

Comparable to conventional rotator cuff repair surgery, REGENETEN Bioinductive Implants can be delivered using arthroscopic or mini-open techniques.4,10 Watch the video below for a technique demonstration.

 

View more technique and insight videos here

Change the way you view and manage rotator cuff pathology

To discuss how REGENETEN could help your patients and practice, contact us.

 

References:
1. Thon SG, O’Malley L, O’Brien MJ, Savoie FH. Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes. Am J Sports Med. 2019;47(8):1901-1908.
2. Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.
3. Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly-porous collagen implant: a 5-year clinical and MRI follow-up. MLTJ. 2019;9(3):338-347.
4. Schlegel TF, Abrams JS, Bushnell BD, Logan Brock J, 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;27(2):242-251.
5. McIntyre LF, Bishai SK, Brown PB, Bushnell BD, Trenhaile SW. Patient-reported outcomes following use of a bioabsorbable collagen implant to treat partial and full-thickness rotator cuff tears. Arthroscopy. 2019 July 23.
6. 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. Muscles, Ligaments Tendons J 2016;6(1):16-25.
7. McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.
8. Smith + Nephew 2020 REGENETEN Collagen Implant Physical Characteristics. Internal Report.
9. Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283.
10. 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. Muscles, Ligaments Tendons J 2015;5(3):144-150.

Ordering Information

Ordering Information
For distribution in the US and its territories only


Implants
Order #      Description
4565          Medium Bioinductive Implant with Arthroscopic Delivery (1)
4566          Large Bioinductive Implant with Arthroscopic Delivery (1)

Anchors
Order #      Description
4403          Bone Anchors (3) with Advanced 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)