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Ô°ÇøÒùÂÒExperience With Cardiovascular Devices
Preclinical Projects Completed in Support of Cardiology Devices
Clinical Cardiovascular Projects Per Year
Trial Subjects
Trial Sites Managed
Overview
Ô°ÇøÒùÂÒhas extensive experience with cardiac, cardiovascular, and neurovascular devices and supports a myriad of these project types annually. The technical specialists and scientists of our cardiovascular CRO are adept at developing preclinical testing programs and evaluating the biocompatibility and functionality of such devices. Working in close collaboration with our specialists, NAMSA’s product development teams are well-versed and experienced in confronting global regulatory, reimbursementÌý²¹²Ô»åÌýcommercialization challenges head-on to achieve accelerated cardiovascular device development outcomes.
Some of the most common cardiovascular clinical research projects include: cardiovascular devices for hypertension; cardiac mapping technologies; coronary saphenous vein grafts (SVG); counterpulsation pump devices; heart failure devices; ICD and RCT therapies; left atrial appendage occlusion devices; left ventricular assist devices (adult and pediatric); orbital atherectomy systems; robotic ablation for atrial fibrillation; and therapeutic lead EP and intravascular ultrasound devices.
Select Cardiovascular Expertise
In addition to thousands of cardiovascular biological safety tests conducted annually by our cardiovascular CRO team, Ô°ÇøÒùÂÒhas completed over 500 customized preclinical studies worldwide. Ô°ÇøÒùÂÒsupports over 300 cardiology projects and cardiovascular clinical research trials per year, and on average, 40 percent of our clinical studies supported involve cardiology or peripheral vascular devices, including:
- Arteriotomy closure
- Beating heart surgery systems
- Cardiac valve repairs
- Cardiopulmonary bypass equipment
- Cardiac catheters
- Coronary guidewires
- Cardiac Resynchronisation Therapy (CRT)
- Coronary stents
- Heart valves (mechanical, tissue, transcatheter)
- Implantable Cardioverter Defibrillators (ICD)
- Implantable Loop
- Recorders (ILR)
- Inferior Vena Cava Filters (IVCF)
- Intravascular Ultrasound Systems (IVUS)
- Mechanical circulatory support Pacemakers
- Pacemaker Device Testing
- Perfusion disposables
- Peripheral thrombectomy
- PV embolization plugs and coils
- Transcatheter Mitral Valve Repair (TMVR)
Within the last five years, Ô°ÇøÒùÂÒhas performed 250 cardiovascularÌý²¹²Ô»åÌý50 peripheral vascular projects in 30 countriesÌý·É¾±³Ù³ó:
- 800 sites
- 8,000 subjects
- 5,000 monitoring visits
- 450 databases built and managed