Identifying Unmet Clinical Need
Research premise for BioMime Morph – Sirolimus Eluting Tapered Coronary Stent System is based on two primary observations from routine
PCIs –
1. Anatomical shape of vessels
2. Procedural concerns associated with stenting of long diffused lesions
Anatomical shape of vessels
• Right coronaries are generally tubular & non-tapering vessels
• Left coronaries generally give off branches & taper→ The vessels usually tend to taper to the tune of 10-15% per
30mm of vessel length
Procedural concerns associated with stenting of long diffused lesions
→ Long diffused lesions need to be treated with multiple stents
→ Multiple stents need to be overlapped
→ Concerns with overlapping DES-
• Vessel rigidity – make the vessel rigid due to excess metal
• Fracture – are more prone to fracture due to rigidity
• Restenosis – cause higher vascular injury leading to restenosis
• Drug overdose – have twice the dose leading to delayed healing
• Polymer inflammation – have twice the polymer dose leading to polymer inflammation
• Aneurysm – excessive drug dose may lead to aneurysms
• Side branch jailing – excess un-organized metal may jail important side branches
• Over radiation – multiple stenting procedure take longer time and expose the operator
to over radiation
• Contrast media – multiple stenting procedure involves more contrast media
• Cost – multiple DES cost more
