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Cardiovascular Device & Peripheral Vascular Device Expertise

MDCI works with cardiovascular device manufacturers to meet clinical, compliance and regulatory requirements to bring the product to market, including:

• Defibrillators
• Pacemakers
• Cardiac stents
• Cardiopulmonary bypass devices (hardware and disposables)
• Minimally invasive surgical instruments
• Vascular prostheses
• Blood vessel filters
• Cardiac monitors
• LVADs – clinical trial monitoring for end-stage heart failure study
• Stem Cells for AMI and CHF – clinical trial monitoring and data management, Data and Safety Monitoring Board (DSMB) and Central Events Committee (CEC),management

Cardiovascular Medical Device Case Study - Ventricular Assist Device

Heart failure is a progressive disorder in which damage to the heart causes weakening of the cardiovascular system. It can also affect the health of a patient's circulation, lungs, and other organs, and often occurs in conjunction with other serious health conditions, including kidney disease, hypertension, vascular disease, and diabetes. Nearly 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. For patients with advanced heart failure symptoms, implantable ventricular assist devices can offer additional treatment options.

A privately held medical device company, with U.S. and international facilities, developed a left ventricular assist system (LVAS) as an option for these very sick patients, intended as a bridge to heart transplantation. This cardiovascular medical device system, comprised of implanted and external components, provides blood flow for the vascular system and reduces the load on the ventricle.

The company selected MDCI to provide full-service support for a clinical trial to evaluate the safety and efficacy of its left ventricular assist system. As the company's CRO and partner, MDCI helped to qualify and initiate multiple clinical study sites, provided ongoing clinical study monitoring , study management, data management, data reporting, and statistical analysis.

Peripheral Vascular Medical Device Case Study

A privately held medical device firm, with offices in the US and Europe, developed a revolutionary and cutting-edge therapeutic approach for treating patients suffering from severe peripheral artery disease (PAD). This serious condition, caused by a hardening and narrowing of the arteries over time due to the buildup of plaque, affects close to 500,000 people worldwide, with about 160,000 cases each year resulting in amputation. The therapeutic approach developed by this company uses a system that is regulated as a peripheral vascular medical device by the FDA. The hope is that use of this medical device will prevent these PAD cases from becoming extreme.

As the company pursued FDA PMA approval for this peripheral vascular medical device treatment, they turned to MDCI to support a multi-year, multi-center investigational study in the United States. Specifically, they needed help with clinical trial monitoring activities, study management, data management and statistical analysis.

By avoiding the expense, training time, and overhead of hiring in-house clinical trial monitors and study managers, and by leveraging MDCI's knowledge of FDA regulatory requirements, the client has realized significant cost-savings while continuing to move their peripheral vascular medical device technology further along the path to FDA PMA approval.

Contact us to learn more about our Cardiovascular Device Expertise.