Therapeutic Areas: Cardiovascular

We have our fingers on the pulse of cardiovascular development.

We know cardiovascular studies are inherently complex, so we’ve developed a progressive approach to make the process less complicated and more adaptable.

Utilizing principles of agile development, borrowed from the software industry,

Proxima streamlines operations and provides continuous improvement, resulting in a quicker delivery of high quality results, without abandoning accuracy or bankrupting your budget.

CardioVascular disease (CVD) Our Process Our Experience

A Worldwide Threat

Cardiovascular Disease (CVD) remains the #1 health threat worldwide,

despite stable and innovative progress in clinical research.

The majority of deaths from CVD occur in developed geographies like North America, the European Union, and Asia

Cardiology &Vasular Interventions

At Proxima Clinical our core specialty in the field of cardiology and vascular interventions are as follows:

CORONARY

STRUCTURAL HEART

PERIPHERAL

01.

EARLY CLINICAL DEVELOPMENT

02.

CLINICAL CRO DELIVERY

03.

CONSULTING

Our Agile CRO Process

Our team of therapeutic and operational experts can support all aspects of clinical and commercial operations, allowing for easier innovation and earlier access to market.

Our trial delivery focuses on agility, efficiency, speed, and a deep understanding of cardiovascular endpoints. We work with class II and class III devices, whether they support a 510(k), PMA, post approval, or observational assessment.

Cardiology & Vascular Experience

Expectations met. Every time.

At Proxima Clinical, we understand the complexities that come with conducting successful clinical trials. We use proven, effective solutions to manage your trial from start to finish.

We know you need a partner that can meet you where you are and get you results within budget, every time.

Our staff is well-versed in a variety of devices, drugs, and technologies and our breadth of experience includes:

Ablation Catheters (CRM; AF)

Bioresorbable Scaffolds

Structural Valves (TAVR, TAVI)

Cardiac Leads

Balloon Catheters

Cardiac Bleeding & Monitoring

Bare Metal Stents

Digital Health & Technology (Apps and Algorithms)

Pacemakers

Drug-Eluting Stents

Implantable Cardioverter-Defibrillators (ICD)

Stem Cells & Alginates

Stent Grafts for PAD

Ventricular Assist Devices (VAD)

Intravenous Catheters Filters (IVC)

Our therapeutic treatment and indication experience span the following areas:

Rhythm Management

Congestive Heart Failure

Valve Repair & Replacement

Pulmonary Embolism

Peripheral Arterial Disease (PAD)

Coronary Arterial Disease (CAD)

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.

Physician

Chester J. Koh, MD

"Proxima staff understood the needs of our company and took a vested interest in supporting our clinical trial’s aggressive timeline while safeguarding our goals and objectives. Proxima has been a true partner for our early stage medical device startup!"

Sr. VP, Marketing & Clinical Development

Zaffer Syed

"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."

COO & Co-Founder

Geoffrey Lucks

I consider myself quite lucky that when I started as Director of Quality at our innovative SaMD start-up, we already were working with Proxima and Ellie Reynolds. It was invaluable to me to have a knowledgeable, collaborative and responsive partner in Ellie to help me build our QMS and to provide hands-on training in our eQMS, Greenlight Guru. Another great benefit of partnering with Proxima was that when extra help or expertise was required, Ellie always was quick to connect me with other resources on the Proxima team.

Director Of Quality

Matt Garrity

Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.