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
Disclaimer: This website page is under construction and the illustratives/procedure displayed, referred for said therapies, are Work in progress drafts developed for general information purposes. All the illustrations on the page are artistic representations and should not be considered as engineering drawings or photographs to scale. The actual procedure performed under the standard operative environment by a medical professional may be different and not similar to the demonstrations portrayed herein and subject to the region-specific regulatory/IP copyrights.
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