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

Limitations of current treatment

• In the present scenario, to treat lesions >48mm one is compelled to use two or more stents
• Anatomical mismatch between currently available cylindrical stents with natural taper of coronary arteries
       → Higher distal diameter has a propensity to cause distal vessel dissection

Long diffused lesion of LAD
requiring two overlapping stents

Cylindrical artery at the stented
site and an abrupt tapered distal to stent