CREDENCE BTK
Peripheral artery disease (PAD) is a condition where narrowed arteries reduce blood flow to the arms & legs, often causing pain and mobility issues.
Treatment options for PAD, especially in the Below-the-Knee (BtK) region, involve the use of Percutaneous Transluminal Angioplasty (PTA) Balloons, Drug-Coated Balloons (DCBs), and/or Drug-Eluting Stents (DES). Combining the advantage of a BioResorbable Scaffold with the anti-proliferative action of drugs is based on the effectiveness of this concept in interventional cardiology. Since the possibility of restenosis is high, particularly in the femoro-popliteal and below-the-knee (BtK) region; it calls for a revolution in the treatment of these diseases.
Credence Below-the-Knee is a Sirolimus-Eluting Bioresorbable Peripheral Scaffold system, an indigenously developed technology by Meril. Credence BtK is designed to treat arterial blockages in the below-the-knee region, thereby preventing further complications with promising results.
Benefits
Sirolimus-eluting bio-resorbable peripheral scaffold system
Drug coating of PDLLA + Sirolimus
Couplets of tri-axial RO markers on both ends (120° apart from each other)
Excellent acute and long-term results with a completely disappearing scaffold
Estimated degradation of scaffold in about 2-3 years
Product Specifications
| Scaffold Backbone | Scaffold Material Scaffold Strut Thickness Scaffold Diameters Scaffold Lengths |
BioResorbable PLLA (Poly L-lactide) 100µm 2.50,3.00,3.50 mm 32,40 mm |
| Scaffold RO Markers | Tri-axial RO Markers | Platinum (Couplets of tri-axial RO markers on both ends, 1200 apart from each other) |
| Top Coat- Drug+Polymer | Drug Equivalent Drug Dose |
Sirolimus 1.25µg/mm2 |
| Delivery System | Delivery System Nominal Pressure (NP) Rated Burst Pressure Balloon Overhang Shaft Outer Diameter Radiopaque Markers Usable Catheter Length Sheath Compatibility |
Rapid Exchange 9atm (Refer lable for more details) 16atm (Refer lable for more details ) <1 mm Proximal :2.13 F,Distal: 2.7F for lineage delivery system 2-Platinum / Iridium 142 cm 0.014" (0.36 mm) |
Clinical Data
| STUDY NAME | TYPE OF STUDY | TOTAL PATIENTS | STATUS | LINKS |
|---|---|---|---|---|
| Credence BTK-1 study | First in man, prospective, multi-center study | 30 | Completed | Know more |
Product IFU
Note: IFU will be displayed after MDR Certification