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cardiovascular device testing

DAY IN OUR LAB allows quick, inexpensive cardiovascular device testing with access to ViVitro equipment and the use of one lab tech for an entire day in Victoria, Canada, or at PROTOMEDLABS in Marseille, France. This low-cost option gives immediate access to ViVitro expertise and equipment. Accelerate your development and decrease your time to market. Options include data collection and/or analysis, high speed video, consultations on technical, quality or regulatory affairs. Clients can engage as many times as they like in this manner.

ViVitro Labs testing expertise covers a wide range of cardiovascular devices. Our cardiovascular device testing products help answer unique design-specific questions as well as perform verification and validation testing. In addition to purchase, our equipment is also available through other lower cost shorter term options including DAY IN OUR LAB, leasing, ViVitro-conducted feasibility, and regulatory testing.

ViVitro equipment is available for purchase, DAY IN OUR LAB, leasing, and ViVitro-conducted feasibility, and regulatory testing.

ViVitro Conducted Testing Our non-accredited cardiovascular device testing service delivers quicker, less costly preliminary evaluation and feasibility testing. Optimal for clients with a discrete number of tests or insufficient time or personal to lease equipment.

The Pulse Duplicator and Ex Vivo Simulator are most useful for looking at pulsatile hydrodynamic data inside the heart. The Pulse Duplicator offers higher repeatability and control while the ex vivo offers more realistic anatomy.

The Ex Vivo simulator is used to test transcatheter devices when realistic anatomy is required. Our Lab team can perform mock animal studies using the Ex Vivo simulator to evaluate your device for functional performance.

The Endovascular Simulator is useful for studying applications outside the heart or for accessing delivery catheter performance.

The HiCycle can be used to determine the durability of replacement heart valves and other cardiac devices under physiological loading for R&D and regulatory submissions. The HiCycle allows testing up to 30 Hz (1850 BPM).

Contact us today to discuss your cardiovascular device testing requirements including:

  • Ventricular Assist devices (VAD, LVAD, RVAD) (ISO 14708-5:2010 Annex DD)
  • Total artificial hearts (TAH) (ISO 14708-5:2010 Annex DD)
  • Occluders or Closure Devices (ASD – Atrial Septal Defect, PFO – Patent Foramen Ovale, ASO – Atrial Septal Occluder, VSD- Ventricular Septal Defect, PDA Patent Ductus Arteriosus, PLD- Paravalvular Leakage Device)
  • Valvular repair or reconstruction devices
  • Shunts
  • Stents
  • Delivery systems
  • Intra-aortic balloon pumps
  • Venous Filters
  • Left atrial appendage (LAA) devices
cardiovascular device testing

Includes:

  • Preparation of an agenda before visit.
  • Holder or device fixturing materials, need details to prepare ahead of visit.
  • Access to one piece of equipment during their visit.
  • Visit supported by ViVitro trained professional staff member to maximize time with the equipment.
  • Unlimited High-speed Video.

Optional Extras:

  • Work with additional pieces of ViVitro equipment during the day.
  • Documentation of results/report.
  • Consultations with QA/Regulatory Staff.

 

cardiovascular device testing

 

ViVitro Labs Advantages

Many companies look to academia to handle their flow visualization experiments due to their low cost.  With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We  understand how critical your timelines are. We work to your schedule and deliver to our commitments.

ISO 17025 Accredited by A2LA
For studies used for regulatory approval this is a must. Our trained researchers, calibrated equipment, and internal audits meet ISO 17025 standards.

Free Set-Up Consultations
All of our pulsatile studies are developed via no-cost, no obligation, collaborative consultation.  We design unique tests to meet specific developmental or regulatory needs.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

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