Donawa Lifescience Consulting has experience across a broad spectrum of therapeutic areas, device class and study types, as indicated below.
European device type/classification:
Over the last five years, one of DLC's principal areas of expertise has been cardiovascular studies, which accounted for around 40 % of the total. Devices, and study indications that DLC has been involved in include:
Implantable device for left ventricular augmentation in patients with dilated cardiomyopathy
Abdominal aortic aneurysm stent graft system
Metal stent for coronary artery lesions
Ventricular assist device
DES in emphysema
Active implantable device for treatment of heart failure
Implantable device for mitral valve regurgitation
Laser catheter for acute myocardial infarction
Implantable wireless device for monitoring left ventricular pressure
Aortic heart valve for the treatment of aortic stenosis
DLC also has significant experience in performance evaluation studies for IVDs. Over the last four years, DLC has been managing a large IVD study with over 2,000 subjects enrolled at 12 sites across Europe, US and Canada. Additionally, DLC has provided full clinical services for a smaller study with over 140 subjects enrolled at 3 sites in Europe and US. For both studies DLC regulatory support included the preparation of 510(k) submissions to FDA.
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