REGENETEN™ Bioinductive Implant System in Full-thickness Tears (REGENETEN)

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone

The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation; Procedure: Arthroscopic rotator cuff repair; Device: Arthroscopic rotator cuff repair for revision surgery

Detailed Description

This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Macquarie University Hospital
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • OrthoSport Victoria
• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2K 4X2
      • Saint John Orthopaedics
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • McMaster University
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital Toronto
• France
  • Montpellier, France, 34430
    • Clinique Saint-Jean - Montpellier
  • Paris, France, 75018
    • Bichat hospital
  • Boulogne-Billancourt
    • Paris, Boulogne-Billancourt, France, 92100
      • Hopital Ambroise Pare
  • Provence-Alpes-Côte d'Azur
    • Nice, Provence-Alpes-Côte d'Azur, France, 06000
      • Hopital Pasteur 2
  • Île-de-France
    • Trappes, Île-de-France, France, 78190
      • Hôpital Privé de l'Ouest Parisien
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Singapore
  • Singapore, Singapore, 169856
    • Singapore General Hospital
• Switzerland
  • Zurich, Switzerland, 8008
    • Schulthess Klinik
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital
• United Kingdom
  • Bristol, United Kingdom, BS105NB
    • Southmead Hospital
  • Lancashire
    • Blackburn, Lancashire, United Kingdom, BB2 3HH
      • Royal Blackburn Hospital
  • Manchester
    • Wythenshawe, Manchester, United Kingdom, M23 9LT
      • University Hospital of South Manchester NHS Foundation Trust
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8XP
      • Liverpool University Hospitals NHS Foundation Trust
  • Middlesex
    • Stanmore, Middlesex, United Kingdom, HA7 4LP
      • Royal National Orthopaedic Hospital NHS Trust
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham University Hospital
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • University Hospitals Coventry and Warwickshire
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B31 2AP
      • The Royal Orthopaedic Hospital NHS Foundation Trust
• United States
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital
  • New York
    • DeWitt, New York, United States, 13214
      • Syracuse Orthopedic Specialists
  • Ohio
    • Cleveland, Ohio, United States, 44125
      • Cleveland Clinic
  • Texas
    • Bedford, Texas, United States, 76021-5011
      • Texas Orthopedic Specialists
    • The Woodlands, Texas, United States, 17201
      • Houston Methodist The Woodlands
  • Wisconsin
    • Ashland, Wisconsin, United States, 54806
      • Ashland Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject requires Arthroscopic rotator cuff repair (ARCR);
2. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed;
3. Subject is > 40 years of age (no upper limit);
4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.

Exclusion Criteria:

1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
2. Subjects with Samilson-Prieto osteoarthritis > 2;
3. Subjects with current or prior infection of the ipsilateral shoulder;
4. Subjects with known hypersensitivity to bovine-derived materials;
5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);
7. Subjects with an irreparable or partially reparable rotator cuff tear;
8. Subjects with a subscapularis tear requiring repair;
9. Subjects requiring a concomitant labral fixation procedure;
10. Subjects requiring a concomitant os acromiale fixation procedure;
11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
14. Subjects who are pregnant or breast feeding;
15. Subjects who are currently involved in any injury litigation or workers compensation claims;
16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;
17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation
18. Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse;
19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARCR augmented with REGENETEN™ Bioinductive Implant; During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.	Device: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation; The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
Sham Comparator: ARCR alone; The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing	Procedure: Arthroscopic rotator cuff repair; The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
Other: Revision group; Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN	Device: Arthroscopic rotator cuff repair for revision surgery; The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retear Rate at 6 Months	Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Retears at 3 Months, 12 Months, and 24 Months	Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).	3 months, 12 months, and 24 months
Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.	Baseline, 3 months, 6 months, 12 months and 24 months
Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index	The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).	Baseline, 3 months, 6 months, 12 months and 24 months
Constant-Murley Score	The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).	Baseline, 3 months, 6 months, 12 months and 24 months
Subjective Shoulder Value (SSV)	The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.	Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score	The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the participant's health state and consists of five dimensions to create an index score for mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.	Baseline, 3 months, 6 months, 12 months and 24 months
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score	The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).	Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Medical Care	The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.	Baseline, 3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain	The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: Excellent; Very Good; Good; Fair; Poor	3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities	The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: Excellent; Very Good; Good; Fair; Poor	3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities	The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: Excellent; Very Good; Good; Fair; Poor	3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations	The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: Excellent; Very Good; Good; Fair; Poor	3 months, 6 months, 12 months and 24 months
Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint	The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: Definitely Yes; Probably Yes; Possibly Not; Definitely Not	3 months, 6 months, 12 months and 24 months
Pain - Visual Analog Scale (VAS) Score	Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).	2 weeks, 6 weeks, 3 months and 6 months
MRI Tendon Findings: Supraspinatus Sugaya Score	The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.	3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Sugaya Score	The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.	3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Supraspinatus Goutallier Classification	Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: Grade 0; Grade I; Grade 2; Grade 3; Grade 4; Unable to assess	3 months, 6 months, 12 months and 24 months
MRI Tendon Findings: Infraspinatus Goutallier Classification	Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: Grade 0; Grade I; Grade 2; Grade 3; Grade 4; Unable to assess	3 months, 6 months, 12 months and 24 months
Total Tendon Thickness	Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).	3 months, 6 months, 12 months and 24 months
Total Tendon Length	Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).	3 months, 6 months, 12 months and 24 months
Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])	Area of retear in millimeters squared (mm^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).	Day 0, 3 months and 6 months
Size of Retear: Anteroposterior (AP) Length	Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).	Day 0, 3 months and 6 months
Size of Retear: Mediolateral (ML) Length	Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).	Day 0, 3 months and 6 months
Shape of Retear: Operative Visit	Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: Crescent; L Shape; Reverse L; U Shape; Massive/Contracted; Unable to Determine	Day 0
Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months	Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: Intact (i.e., no re-tear); Crescent; Longitudinal; Massive; Unable to Determine	3 months, 6 months, 12 months and 24 months
Return to Work Questionnaire	Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: Returned to work?; Have you been able to return to the job you did before your surgery?; Did you feel ready to go back to work physically?; Since returning to work, any time off due to shoulder pain or weakness?; Since last follow-up visit did you take additional time off due to shoulder pain/weakness?	2 weeks, 6 weeks, 3 months and 6 months
Return to Work Questionnaire: Reason for Not Getting Back to Work	The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: Physical capability; Safety; Motivation; Other	2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Reason Couldn't Return to Activities	The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: Physical capability; Safety; Motivation; Other	2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Time Off	Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.	2 weeks, 6 weeks, 3 months, 6 months
Return to Work Questionnaire: Duration Away From Work (Days)	Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work	2 weeks, 6 weeks, 3 months, 6 months
Duration of Opioid Use	Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.	Following surgery, up to 14 days
Opioid Use for More Than 5 Days Post-Surgery	Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.	Following surgery, up to 14 days
Total Operative Time	Total operative time in minutes.	Intraoperative
Sling Type	The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: Standard Sling; Shoulder Immobilizer; Sling and Swathe; Abduction Sling; External Rotation Sling; Other; Missing	up to 3 months
Mobilization Time in Sling	Mobilization time was the duration, measured in weeks, that participants spent in a sling.	up to 3 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Chris Peach, MBBS MD FRCS (Tr&Orth), Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rotator cuff tendon; Full thickness tears; REGENETEN Bioinductive Implant System
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REGENETEN.2020.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes