Smith+Nephew’s Regeneten Bioinductive Implant Receives CE Mark

Smith+Nephew’s Regeneten Bioinductive Implant has successfully received CE Mark certification allowing the implant to now be used and sold in key European markets. More than 40,000 procedures have already been completed since its U.S. introduction.
 
The collagen-based Regeneten Bioinductive Implant supports the body’s natural healing response by inducing the growth of new tendon-like tissue^1-3,6 to biologically augment the existing tendon and disrupt disease progression.^1-5 Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and is completely resorbed within six months.*⁷
 
“This is the most exciting advance in the field of rotator cuff surgery in my career and has the prospect of completely transforming patient outcomes,” commented Chris Peach, consultant shoulder and elbow surgeon, Orthteam Centre, UK and chairman of the Research Committee of the British Elbow and Shoulder Society.
 
The Regeneten Bioinductive Implant arrives in Europe with extensive clinical evidence covering the entire spectrum of rotator cuff disease, from partial thickness tears² to difficult-to-treat large (3-5cm) and massive (5cm+) thickness tears⁶.
 
“I am very excited about this new product. Biological enhancement and tendon regeneration is the way forward. I believe Regeneten is changing the way we think about and manage rotator cuff pathology. We can now expect consistent improvement in patient outcomes,” commented Carlos Cobiella LMS FRCS Ed (Tr & Orth), consultant shoulder & elbow and sports surgeon, University College Hospital, London, UK.
 
The implant will be available to use on the 310,000+ rotator cuff procedures that take place each year in Europe in a market that is worth an estimated $175 million annually⁸.
 
*On human biopsy (n=1) and in-vivo sampling
 
References:
¹ 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.
² 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. 2018 27(2):242-251.
³ 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.
⁴ 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. Muscles, Ligaments Tendons J 2019;9(3):338-347.
⁵ 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.
⁶ 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.
⁷ 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
⁸ Smith+Nephew, Internal Market Procedure Data