Envision Scientific Pvt. Ltd., is an affiliated company of Concept Medical and is the sole manufacturing entity.
With the goal to provide all the life-changing medical devices, Envision Scientific Pvt ltd, sets the stage for Concept Medical by putting its heart into manufacturing.
Envision Scientific was established in the year 2008. It is involved in research, development, and manufacturing of innovative products and methods for the treatment of cardiovascular and peripheral diseases. It has successfully developed in drug- delivery systems to address the unmet medical needs in coronary and peripheral artery disease. The ESPL has State- of- art manufacturing unit set up at Hazira and Special Economic Zone (SEZ), Sachin in Surat will cater to the international and domestic markets.
Envision Scientific is a company pioneering in the development of Nanotechnology-based applications for drug delivery with devices like Drug-Eluting Stents and Drug-Coated Balloons for Coronary and Peripheral applications.
Envision Scientific has a well-defined Quality Management System in accordance with the standard requirements. Both the Manufacturing Units are ISO 9001:2015, ISO 13485:2016, EN ISO 13485:2016, and ISO/IEC 17025:2017 certified and approved by CDSCO India in compliance with Medical Device Rules, 2017.
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2008
Idea to Inception
Started a small innovation chamber in Cleveland. Ohio and Formulation of R&D facility
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2009
The process of innovation gets a kick start
Success in experimentation of Sirolimus Drug Coating
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2010
Innovation to Validation
DTF labelled study conducted successfully By Dr. Renu Virmani, validates the innovativeness of MagicTouch.
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2011
Crest now has an establishment
- Manufacturing Facility stands tall.
- Approved by Indian FDA
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2012
Innovation in action
First human implant of MagicTouch in Nanolute registry & Abluminus DES+ in en-ABL 1
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2013
Innovation is Stamped
First US patent granted followed by many more
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2014
The World knows Innovation
CE approval of World’s first Sirolimus Coated Stent
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2015
The Innovation speaks for itself
First case report of sirolimus coated balloon with follow-up published
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2016
Presence is felt all over the globe
CE approval received for world’s first Sirolimus Coated Balloon, Export to all over Europe commence.
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2017
Recognition of Innovation
Awarded by CII – ONE OF THE TOP 26 INNOVATIVE ORGANIZATION
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2018
Trend of application continues
- CE approval received for Abluminus with on label indication for DM and AMI
- National technology Award received from then Hon. President of India.
- Discussion of IDE intiated with USFDA
- Extensive European & Indian Clinical data generated
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2019
Concept Medical leaves the world in an awe
- Breakthrough Device Designation received for MagicTouch, MagicTouch PTA & MagicTouch AVF for various indication
- PMDA approval received for clinical study in Japan
- CE approval for MagicTouch PTA, MagicTouch AVF and MagicTouch ED
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2020
Concept Medical has only just begun
- Grand Opening of Asia’s Largest Manufacturing Unit of Drug Coated Balloon & Drug Eluting Stent
- MagicTouch receives Breakthrough Device Designation for application in small coronary vessel
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2021
Concept Medical continues to amaze
Submission made to USFDA for IDE status for MagicTouch
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2022
1st US FDA IDE
Concept Medical becomes Game Changer Receives First US FDA IDE approval
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2023
Three More US FDA IDE Approvals
- Granted the second Investigational Device Exemption (IDE) approval in Below the Knee (BTK) indication, for its Sirolimus coated balloon Magic Touch PTA.
- MagicTouch SCB granted the third US FDA IDE approval for the treatment of Small Vessels (SV) in Coronary Arteries.
- Granted fourth US FDA IDE approval for MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA).
Envision Scientific is a company pioneering in the development of Nanotechnology based applications for delivery. Envision Scientific has developed a novel polymer free nanocarrier based drug delivery system in its R&D Lab.
