CVECT Cardiovascular and Extracorporeal Technologies

TECHNOLOGY ASSESSMENT

CVECT offers assessments of medical technology for

  •  The company considering acquisition
  •   The developer of an emerging technology
  •   Independent evaluation at any phase of product development

CVECT assists in refinement or preclinical development, and market identification.

 

SERVICES TO CLIENTS AND INDUSTRY

CVECT is able to offer a wide range of services to manufacturers of medical technology. Of these are:

   Pre-clinical services:

  • In-vivo and in-vitro model development for product testing and evaluation
  • Cardiovascular pharmaceutical evaluation in the peri-operative setting
  • Pre-clinical GLP animal and in-vitro (mock circulation) models for pre-IND, Pre and intra-IDE and Pre-PMA GLP evaluations
  • Device testing and evaluation; design of accurate in-vitro or ex-vivo bench systems for precise evaluation adhering to AAMI and FDA regulations
  • Full Service Laboratory Animal Investigations; study design, implementation, and management; regulatory support and coordination
  • Technical support during development

Specialist Training:

  • Staff: sales, technical, research and development
  • Customer Training
  • Proprietary Cadaveric Beating Heart Model Available For High Fidelity and Dynamic Surgical Experience

Clinical services with product applications:

  • Market identification and integration, both domestically and internationally. Technical support to customers
  • Technical support to distributors, sales force
  • Data collection and management (e.g.: field trials)
  • Technical support to marketing efforts

CVECT intends to be highly flexible in its approach to the requirements of each Client. Potential clients are asked to discuss their requirements early in their planning to maximize cost savings and marketing potential.

 

RECENT PROJECTS

  • Global Sales and Technical Training Program for physicians and sales personnel utilizing CVECT Beating Heart Cadaveric Model

  • Management and coordination of NIH and Industry Joint-Sponsored project to evaluate bio-synthetic thrombocytes in a survival in-vivo model testing efficacy, long-term storage, and impact on trauma ($1.8 mil budgeted project completed $275,000 under budget and 3 mos. ahead of schedule)

  • Complete product research and development, project management, and execution for near-infra-red physiologic biochemistry monitor with trauma applications in the battlefield 

  • Percutaneous surgical placement of trans-ventricular tethers for restriction of a ventricular aneurysm model

  • First-in-animal model development and evaluation of a stented aortic and mitral valve assembly for percutaneous delivery

  • Development of multiple technologies for the treatment of cancer and HIV infections (patents)

  • In-vivo and in-vitro model development for surgical technology and anesthesia management

  • Development of an interactive perfusion controller with multiple temperatures, pressures, and control algorithm

  • Software-controlled medical treatment devices for patient treatment processes (patents)

  • New perfusion device components: blood pump, heat exchangers, tubing components (patents)

  • Identification of new biomaterials for use in cardiopulmonary bypass, vascular prostheses

  • Investigation into surface modification technology for biocompatibility enhancement

  • Isolated organ perfusion technology- support systems for transplant organs using blood analogues

  • Design and development of a miniature organ preservation and perfusion apparatus; incorporates disposable technology

  • Gas exchange evaluation techniques for oxygenation devices: in-vitro, ex-vivo, in-vivo models

  • Training and education programs for surgical technology manufacturer: anatomy and physiology, surgical technique, cardiovascular technology

  • Product test program for genitourinary prosthesis; clinical implant protocol monitoring

  • Training and demonstration device for circulatory support devices

  • Completion of FDA 510K application for blood contact disposable products; fulfilled all stages of the application: filing and registration of the manufacturer, in-vitro blood testing, in-vivo protocol development and implementation, and completion of the filing process

  • Establishment of a confidential and private laboratory facility with microemboli detection and quantification capability