Averion - Your Medical Device CRO

The medical device world is very challenging for companies desiring to gain  approval for a new product. Since the majority of device filings are made by companies with a single product, it helps to have an expert CRO available before approaching regulatory agencies. Averion provides first-hand expertise in addressing the following strategic questions:

• Is a 510(k) justifiable?
• Is a feasibility study necessary?
• Should we pursue a PDP or letter of determination?
• What written guidance and precedents are applicable?
• Can foreign data be utilized to support registration?
• What experimental design and control group are most appropriate?
• What primary study endpoints lead to the smallest sample sizes?
• Will the FDA/EMEA accept a composite endpoint?
• How do 21 CFR 812 and 21 CFR Part 11 apply?
• Can Bayesian modeling be beneficial?

At Averion, we have specialized in medical devices for over 25+ years. To date, we have conducted nearly 200 medical device studies and helped clients gain PMA or HDE approval for 30 products. 

Averion's Device Experiences includes:

• Adhesion Prevention Therapies - Spine, Laminotomy, Pelvic, Abdominal, and Cardiac
• Bone Mineral Densitometer
• Cardiovascular Devices:
  • Angina Relief (TMR -Transmyocardial Laser Revascularization)
  • Angioplasty
  • Biventricular Pacemaker
  • Cardiac Defibrillators
  • Cardiogenic Shock Devices
  • Circulatory Assist Devices
  • Cardiac Arrythmia Cryoablation
  • Femoral Artery Closure
  • Implantable Replacement Heart
  • Stents
  • Vena Cava Filter
• Imaging devices - CIN 2/3 disease detection, MRI, breast lesions
• Joint Injection Therapies - Shoulder, Hip, Knee & Thumb
• Maxillofacial- bone growth factor, dental implants, periodontal tissue regeneration
• Oncology Devices:
  • Cervical Dysplasia Flourescence Laser
  • Metastatic Pain Relief
  • Prostate and Ovarian Cancer Biomarker
  • Tumor Ablation Systems
• Organ Failure Bridging Devices - Heart, Liver and Kidney
• Orthopedic Implants - Spine, Hip, Knee, Finger, and Rib
• Wound Healing Adjuncts - Ankle, Fracture Healing,  Burns, and Foot & Leg Ulcers
  

Collectively, we bring deep understanding of regulatory rules, CMS thinking, precedents, and division-specific concerns from a unified regulatory, reimbursement, clinical, and statistical perspective. We offer the highest level of credibility and success to your team.   Our approval record hightlights our successes, we helped our clients gain 30 PMA and HDE approvals.