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Therapeutic Areas Cardiovascular

Cardiovascular

Heart disease demands technologies that are both revolutionary and reliable. Avania is MedTech’s trusted champion: purpose-built to navigate the full cardiovascular lifecycle with precision, agility, and deep therapeutic insight.

Our MedTech focus means we understand the unique complexity of cardiovascular development, from intricate regulatory pathways and advanced imaging to interventional procedures and extended follow-up. With a team of former regulators, trialists, and practicing cardiologists, we bring clarity to complexity and partnership to every milestone.

Connect with Our Cardiovascular Experts
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Navigating the Unique Challenges of

Cardiovascular Device Development

No two cardiovascular devices are alike; each requires its own ecosystem of partners, specialized workflows, and precise regulatory navigation. From imaging, CEC, and DMC oversight to long-term follow-up, these studies demand expertise that only a MedTech-dedicated CRO can deliver.

Avania’s Quality Management System is purpose-built for medical technology: agile, transparent, and free from the rigidity of pharma-first processes. We’ve solved the problems others are just discovering, bringing proven experience across percutaneous interventions, structural heart therapies, electrophysiology, and endovascular procedures.

With integrated teams and a deep understanding of regulatory and technical complexity, Avania helps you move confidently through every stage of cardiovascular device development, from strategy to submission and beyond.

Unparalleled Expertise:

Meet Our Cardiovascular MedTech Veterans

sujith shetty

VP Cardiovascular & Neurovascular Franchise Head (US)

Dr. Suji Shetty, MBBS

  • Previously a research fellow at USC Keck School of Medicine in Cardiology and Pulmonary and Critical Care
  • Led multiple clinical research teams through FDA approval for pre-market and pivotal clinical trials
  • Worked directly with the FDA on initiatives such as the EFS program, EAP process, and Payor Communication Task Force
Bonnie Weiner

Medical Director (US)

Dr. Bonnie Weiner, MD

  • Cardiologist in Worcester, MA, affiliated with St. Vincent Hospital
  • Nearly 30 years of experience; received medical degree from OHSU School of Medicine
  • Supports safety oversight at Avania and manages core imaging laboratory operations
steven bailey

Interventional Cardiology & Structural Heart Disease

Dr. Steven Bailey

  • Current Role: Chairman, Department of Medicine; Malcolm Feist Chair of Interventional Cardiology, LSU Health Shreveport
  • Previous Roles: Tenured & Emeritus Professor of Medicine & Radiology; Former Chief, Division of Cardiology, University of Texas Health Science Center, San Antonio
  • Clinical Focus: Adult congenital/structural and valvular heart disease, coronary atherosclerotic disease
  • Leadership: Past President, Society for Cardiovascular Angiography and Interventions (SCAI)
micheal katcher

Electrophysiology & Cardiac Arrhythmias

Dr. Michael Katcher

  • Cardiologist and Electrophysiologist at Mass General Brigham and Mass General Hospital
  • Clinical interests: Acute MI, AFib surgery, Cardiac Arrhythmias and Electrophysiology, Congestive Heart Failure, and Coronary Heart Disease/Coronary Artery Disease
  • Experienced clinical trialist, served on CEC and DMC boards at Avania
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The Avania Team Advantage

Avania’s cardiovascular experts bring unmatched experience across regulatory, clinical, and procedural domains, led by MedTech veterans who’ve sat where our clients sit. Our specialists include former regulatory reviewers, clinical trialists, and practicing interventional cardiologists who understand the nuance of every device, indication, and submission.

We build the right-sized team for every study, blending clinical, medical, and regulatory expertise to guide your program from first-in-human through global pivotal trials.

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Deep Therapeutic & Industry Insight

With backgrounds spanning device companies, clinical practice, and core labs, our experts anticipate challenges early and chart the most efficient, compliant path to approval. This deep therapeutic perspective — rooted in real-world cardiovascular experience — ensures smarter studies and faster, more confident decisions from design through commercialization.

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Consistent, Dedicated & Flexible Teams

Continuity is built into our model. With low staff turnover and direct access to senior-level experts, you gain true partners who know your study inside and out. Responsive, collaborative, and proactive, our teams integrate seamlessly with yours to deliver quality, efficiency, and long-term success.

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Integrated Solutions for Cardiovascular Innovation

Avania provides comprehensive, multidisciplinary support across the entire cardiovascular product journey, leveraging a combination of regulatory, engineering, and commercial expertise to advance your innovation from concept to commercialization. We’re purpose-built to serve the entire MedTech lifecycle, with unmatched expertise across regulatory, clinical, engineering, and commercial domains.

Strategic Consulting & Regulatory Pathways

With more than 400 regulatory interactions and over 100 FDA meetings led by our SMEs, Avania brings unmatched depth in cardiovascular regulatory strategy. We guide you through PMA, IDE, and breakthrough device designations with precision and proven experience.

Our global regulatory team supports submissions across multiple regions, helping you navigate complex requirements efficiently while setting the foundation for commercial success.

Clinical Development & Execution

Avania delivers excellence in cardiovascular clinical trials, combining scientific rigor, operational precision, and quality oversight from start to finish.

Our expertise spans site selection, imaging integration, CEC/DMC coordination, and real-time data management, ensuring seamless execution at every stage. With relentless focus on quality, patient safety, and regulatory compliance, we help you reach milestones faster and with confidence.

Our Track Record

Demonstrated Success in Cardiovascular

Avania’s cardiovascular expertise spans the full spectrum of device innovation, from early feasibility to global commercialization. Our experience covers:

  • Bare-metal stents
  • Drug-eluting stents
  • Drug-coated balloons
  • Chronic total occlusion (CTO) devices
  • Robotic-assisted interventions
  • Embolic agents
  • Flow diverters
  • Carotid stents
  • Transcatheter aortic valve implantation/repair (TAVI/TAVR)
  • Transcatheter mitral valve repair/replacement
  • Transcatheter tricuspid valve repair/replacement
  • Epicardial and endocardial left atrial appendage (LAA) management
  • Transseptal sheaths
  • Intracardiac septal closure devices
  • Ventricular septal defect (VSD) repair
  • Left atrial appendage ligation
  • Cardiac rhythm management/implantable cardiac defibrillators (ICDs)
  • Epicardial and endocardial cryoablation devices
  • Epicardial and endocardial radiofrequency ablation devices
  • Endocardial laser ablation devices
  • EP mapping systems
  • Devices modulating hypertension
  • Ventricular assist devices (VAD), including pediatrics
  • Extracorporeal membrane oxygenation (ECMO) devices
  • Implantable devices for pulmonary hypertension
  • Blood filters
  • Gene therapy
  • Surgical bypass grafts
  • Resorbable surgical hemostatic and sealant agents
  • Cardiac adhesion prevention
  • Cardiopulmonary bypass (CPB)
  • Vascular closure devices
  • Angioplasty and peripheral arterial disease (PAD) treatment
  • Peripheral venous stenting
  • Occlusion perfusion balloon catheters to repair aortic aneurysms
  • Endovascular aneurysm repair (EVAR) stent grafts
  • Arteriovenous (AV) stents
  • Atherectomy for PAD
  • Thrombectomy for PAD
  • Thrombolysis for deep vein thrombosis
  • Aortic stenosis detection
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Client

Successes

Our clients consistently highlight Avania’s understanding of unique study aspects, structural communication, and flexibility as key differentiators in their success.

Case Study

Driving Academic Trial Success Within Constraints

Device:

Transcatheter aortic valve replacement (TAVR)

Solution:

Flex study resources as the data bolus at sites ebbed and flowed across a long duration and amidst the pandemic

Problem:

Academic led study with limited sponsor investment available and difficult program to enroll

Outcome:

Study completed within budget and at high quality, earning marks from the academic CRO and industry sponsor, and leading to several publications for the investigators and study team

Case Study

Achieving Enrollment Momentum Through Strategic Alignment

Device:

Transcatheter aortic valve replacement (TAVR) system for the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation

Solution:

Strategically align CRAs across national sites and deploy a skilled team of CRAs under a consistent clinical lead

Problem:

Challenging, lengthy enrollment period

Outcome:

Sponsor underwent a very successful acquisition during the study execution, including presentation of outcome data at premier cardiovascular conferences

Case Study

Delivering Dual-Region Trial Leadership From FIH to IDE

Device:

Transcatheter aortic valve replacement (TAVR) accessory device

Solution:

Avania lead full-service trial support across project management, clinical oversight, clinical operations, data management, safety oversight, CEC & DMC oversight and statistics

Problem:

Sponsor had minimal US team presence and needed a strategic partner with strong, dual operations across EU and US

Outcome:

Successful partnership from FIH and CE Mark, and supporting the study design and FDA IDE submission for the IDE approved pivotal program

Case Study

Unifying Global Operations for TMVR Trial Execution

Device:

Transcatheter Mitral Valve Replacement (TMVR)

Solution:

Consolidate vendors under one roof, Avania, for global regulatory and clinical trial execution support across Europe and US

Problem:

Sponsor had selected regional CRO’s in a piece meal, daisy chain approach to trial management

Outcome:

Multi-regional EFS on-going, with Avania leading the global regulatory and clinical study execution in partnership with the sponsor

Case Study

Securing PMA Approval Through Cohesive Clinical Partnership

Device:

Radiofrequency cardiac ablation for treatment of atrial fibrillation (Afib)

Solution:

Avania supported study design, trial execution, PMA submission, and AdCom panel prep and execution

Problem:

Strong EU & US regulatory and clinical operations partner needed to supplement in-house departments that could work as a cohesive team

Outcome:

PMA approval and panel ‘Yes’ vote, shaping the industry approach to catheter ablation in the treatment of Afib

Partner with Avania’s

Cardiovascular Experts Today

From early strategy through global commercialization, Avania’s cardiovascular experts bring the precision, partnership, and purpose-built expertise your innovation deserves. With deep experience across TAVR, LAAC, PFA, and more, we help you advance with clarity, confidence, and speed.

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