N-ovative Health Technologies (NHT) presents REJUVENATE®, an easily deployable coronary stent system that provides a mechanism to open up a blocked or nearly blocked coronary artery and to keep it functional by planting the stent as a support at the damaged region. REJUVENATE® provides great tensile strength and verified vascular biomechanical properties which enable the user to function normally.
Technical Details
The Bare Metal Stent has an MP35NLT Cobalt-Chromium (major elements include cobalt, nickel, chromium) stent platform and is pre-mounted on a PTCA Balloon Dilatation Catheter.
Key Features
- Low recoil
- Superior Cobalt Chromium alloy
- Optimum crossing profile
- Optimal crush resistance
- Excellent biocompatibility
- Optimum durability
- Outstanding deliverability
- - Hydrophilic coated distal shaft
- - Superior trackability
- - Low lesion entry profile
REJUVENATE® Technical and Performance Specifications
| REJUVENATE® Stent Length (mm) | |||||||
|---|---|---|---|---|---|---|---|
| Balloon Catheter Diameter (mm) | 8 | 12 | 16 | 18 | 22 | 26 | 30 |
| 2.00 | A18008 / B20012 | A18012 / B20016 | A18016 / B20020 | A18018 / B20022 | A18022 / B20026 | A18026 / B20030 | A18030 / B20034 |
| 2.50 | A18008 / B25012 | A18012 / B25016 | A18016 / B25020 | A18018 / B25022 | A18022 / B25026 | A18026 / B25030 | A18030 / B25034 |
| 3.00 | A18008 / B30012 | A18012 / B30016 | A18016 / B30020 | A18018 / B30022 | A18022 / B30026 | A18026 / B30030 | A18030 / B30034 |
| 3.50 | A18008 / B35012 | A18012 / B35016 | A18016 / B35020 | A18018 / B35022 | A18022 / B35026 | A18026 / B35030 | A18030 / B35034 |
| 4.00 | A18008 / B40012 | A18012 / B40016 | A18016 / B40020 | A18018 / B40022 | A18022 / B40026 | A18026 / B40030 | A18030 / B40034 |
Product Registration Number: MDMR-000080
CE Certification is in process
Product Readiness
The REJUVENATE® stent system has successfully passed the following clinical evaluation stages:
- Physico-Chemical Testing (ISO 25539) – conducted at Heinz Schade, GmbH, Germany
- Animal trials – conducted at the Centre for Cardiovascular Research and Development, American Heart of Poland
- Human trials – conducted in coordination with top scientists at Emory University, Atlanta, Georgia, USA
- Registered by Drug Regulatory Authority of Pakistan (DRAP)
Product Illustrations
REJUVENATE® stent system comprises two components
Cardiovascular Implant
Cobalt-Chromium Bare Metal Stent
Delivery System
Rapid Exchange Semi Compliant Percutaneous Transluminal Angioplasty (PTCA) Balloon Catheter
Stent is mounted (crimped) on balloon portion of catheter
- Gauge length of balloon is always kept 2±0.5 mm larger than the total length of stent.
- Length of stent has a tolerance of ±0.5mm.
- X-ray marker is placed inside the edge of gauge length of balloon, X-ray marker’s width is 1±0.25 mm.
- Stent is placed in between two X-ray markers; distance from edge to edge of stent and X-ray marker is 1±0.5mm on each side.
Product Standard Compliance
REJUVENATE® stent is manufactured using biocompatible materials in compliance with EN ISO 10993-1 and is safe and compatible to Magnetic Resonance Imaging (MRI) environment in compliance with ASTM F2503, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213.
REJUVENATE® stent has the ability to access and accurately deploy in coronary artery with fixation effectiveness keeping stent integrity with appropriate sizing to maintain luminal patency and improve luminal diameter of artery with minimum haemostasis, having ability of easy withdrawal in compliance with EN ISO 14630 and DIN EN ISO 25539-2.
