Cardiovascular/Cardiac Devices
Alquest possesses a vast amount of experience in cardiovascular, endovascular and implantable cardiac devices, ranging from EP, interventional, cardiac assist, monitoring, cell therapies, diagnostic, peripheral vascular, cardiac ablation, pacing, defibrillators, AAA, drug-eluting and bare metal stents, ASD, closure devices, balloons, pumps, leads, valves, angioplasty, grafts, atherectomy, PTCA, synthetic vessels, LVADs, cardiopulmonary bypass, extracorporeal cardiac assist, oxygenators, cardioplegia, filters, tissue engineering, ECG and angiographic testing, to congenital defects.
Following is a partial list of staff experience.
Alquest Staff Experience
Interventional Cardiology
Product Type |
Assignment |
|---|---|
| Self-expanding stent |
Management of 1,700-patient, 40-site IDE trial of self-expanding stent |
Distal protection + stent |
Management of 1,600-patient, 60 site IDE trial of distal protection + stent |
| Bare metal stent |
Management of 200-patient, 20-site trial of bare metal stent |
Bare metal stent |
Statistical analysis for 1,700-patient IDE stent trial |
Drug eluting stent |
Statistical analysis for 15,000-patient post-market trial for drug eluting stent |
Embolic filter with carotid stent |
Full clinical trial support for IDE pivotal trial (35 sites, 250 patients) |
Coronary saphenous vein graft (SVG) |
IDE for bovine graft used for coronary artery graft clinical trial |
Left atrial appendage occlusion device |
Study design; clinical monitoring of 57 sites; BIMO audit preparation; PMA panel meeting preparation |
Orbital atherectomy system |
Clinical trial management: conducted and managed site visits; site qualifications; study initiation; routine monitoring through closeout visits |
Therapeutic lead EP & intravascular ultrasound |
Full-service clinical trial management |
Coronary guide wire
(for ICDs) |
Protocol writing; report writing; management of Adverse Events |
Embolic protection device (carotid artery) |
Biostatistics; data management (EDC); clinical monitoring (40 sites, 250 patients) |
Percutaneous mitral valve repair device |
Regulatory strategy; protocol review; Quality system support |
Ventricular (VADs) and Cardiac Assist Devices
| Bridge-to-LVAD, portable external pump |
Full clinical trial support |
|---|---|
Pediatric LVAD |
Clinical monitoring; data management through INTERMACS |
LVAD |
Data management for IDE and registry studies (EDC system); data management for OUS study |
Miscellaneous Cardiovascular/Cardiac Devices
PFO occlusion device |
Clinical, statistical and regulatory submission support for Humanitarian Device Exemption (HDE);
Quality Systems audits; internal audit training (MDD); GCP training; clinical audits |
|---|---|
Percutaneous occlusion device for Atrial Septal Defects (ASD) |
Protocol development; CRF development; pre-IDE and IDE support; statistical analysis plan; study sample size calculation; literature review; DSMB-CEC support; final clinical report; event failure analysis; regulatory submission support for Humanitarian Device Exemption (HDE) |
Electrocardiographic detector of myocardial ischemia |
Regulatory/clinical assessment; protocol review |
Algorithms
for detection of ventricular and atrial arrhythmias |
Quality System support |
Embolic protection devices for carotid artery stenting and saphenous vein grafts (SVG) |
DSMB support |
Excimer laser catheters |
Audit preparation |
|
Venous access device |
General regulatory support; CRA support; clinical monitoring; data entry; site management; CEC meeting support; clinical audit |