Your Ideal Partner

The multi-disciplinary WCRO team combines their expert understanding of efficacy, safety, performance and regulatory guidelines to develop optimal Cardiovascular Device testing strategies adapted for your cardiovascular device, which are necessary to bring it to market. The WCRO package of services enables us to partner with you through the various stages of the development process, from conception to widespread market use.

To ensure success, we help our clients:

  • Plan and conduct Cardiovascular studies for device and cardiac safety and efficacy
  • Discover all necessary outcomes for reimbursement using our WCRO-development approval methodology
  • Maintain high levels of compliance after regulatory and payer approval

WCRO can take on projects of any complexity with experience in the following areas and more:

  • Cardiac Diagnostics Devices
  • Cardiac Electrophysiology Devices
  • Interventional Cardiology Devices
  • Intracardiac Septal Closure Devices
  • Structural Heart Devices
  • Vascular Surgery Devices

WCRO Cardiovascular Device Case Studies

Frequently Asked Questions

What is a cardiac or vascular medical device?

Cardiovascular devices are comprised of an assortment of implantable products that seek to treat or prevent diseases of the heart or diseases of the cardiovascular system. These devices can either be implanted surgically by a cardiac or vascular surgeon or percutaneously via a transcatheter approach performed by an interventional cardiologist or radiologist.

These devices are most often grouped in the following categories:

  • Coronary and Peripheral Interventions
  • Electrophysiology and Heart Failure Therapies
  • Structural Heart Interventions

How can a CRO improve my preclinical medical device study plan?

Cardiovascular Devices are subject to significant oversight by medical device regulators globally because they pose a greater risk to patients. Additionally, because each cardiovascular implant and combination product is different, there is no universal study plan. A CRO, like WCRO, is valuable because it allows companies to benefit from years of expertise of experts who can be flexible in development and modifying study designs and support the clients as they strive to meet and exceed the expectations of regulatory bodies. WCRO works with a large and diverse collection of Cardiovascular Device types in development and our experts use their demonstrable experience and understanding of fundamental requirements (e.g. efficacy, safety, performance and regulatory guidelines) to develop the correct strategy for your device.

This combination of expertise and a thorough portfolio of services allows WCRO to create customized plans that carry you from the earliest stages of study design to GLP assessments, so you can get to market soonER and be profitable faster.

What should I consider when selecting a Cardiovascular Device partner?

There are several considerations for selecting a Cardiovascular Device partner, but one stands above the rest. For best success, you must be comfortable that your prospective partner understands the unique requirements and can customize study plans that this category of device requires. This is paramount and the difference between a streamlined, effective study plan and failed trials that lead to rejected submissions. Our specialized Cardiovascular Device program tailors protocols to your device under the direction of experienced and dedicated study directors, board-certified cardiologists and pathologists familiar with the relevant preclinical cardiovascular studies. This expertise allows us to create a customized pathway to bring you from the first step of study design through submissions, approvals and into the market seamlessly and economically.

Learn More about our Cardiovascular Services

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