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
• 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
Technical Specification
| Stent System | Stent Material | Cobalt Chromium L605 | |
| Strut Thickness | 65 µm | ||
| Stent Diameter | 2.75-2.25, 3.00-2.50, 3.50-3.00 mm | ||
| Stent Lengths | 30, 40, 50, 60 mm | ||
| Mean Recoil | 3% | ||
| Mean Foreshortening | 0.29% |
| Drug / Polymer | Drug | Sirolimus | |
| Equivalent Drug Dose | 1.25 µg / mm2 of stent surface area | ||
| Polymer | Biodegradable and Biocompatible |
| Delivery System | Delivery System | Rapid Exchange | |
| Stent Diameter (mm) | Crossing Profile (mm / inches) | ||
| 2.75 - 2.25 | 0.93 / 0.037” | ||
| 3.00 - 2.50 | 0.99 / 0.039” | ||
| 3.50 - 3.00 | 1.03 / 0.040” | ||
| Usable Catheter Length | 142 cm | ||
| Balloon Characteristics | Semi-compliant | ||
| Balloon Overhang | < 0.5 mm | ||
| Radioopaque Markers | 2 – Platinum / Iridium | ||
| Nominal Pressure | 9 ATM | ||
| Rated Burst Pressure | 14 ATM | ||
| Shaft Outer Diameter | Proximal 2.13 F; Distal 2.7 F | ||
| Guide Catheter Compatibility | 5 F (Min. I.D. 1.42 mm / 0.056”) | ||
| Max. Guide Wire | 0.014” (0.36 mm) |
Configurations
| Diameters | Lengths | |||
|---|---|---|---|---|
| Proximal - Distal | 30 mm | 40 mm | 50 mm | 60 mm |
| 2.75-2.25 mm | BIM27522530 | BIM27522540 | BIM27522550 | BIM27522560 |
| 3.00-2.50 mm | BIM30025030 | BIM30025040 | BIM30025050 | BIM30025060 |
| 3.50-3.00 mm | BIM35030030 | BIM35030040 | BIM35030050 | BIM35030060 |