Thursday, September 29, 2022
News
NEWS HOME
»
PRN INDIA
MedAlliance SELUTION SLR Receives Second FDA IDE Approval
  SocialTwist Tell-a-Friend  
   

GENEVA, Aug. 10, 2022 /PRNewswire/ --  SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022).

Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centers in the US and an additional 20 centers around the world. This study will enroll 300 patients to demonstrate superiority over balloon angioplasty (POBA). The Principal Investigator of this study is Dr George Adams, Director, Cardiovascular and Peripheral Vascular Research; Rex Hospital Inc., Raleigh, North Carolina, United States.

"We are very excited that US patients suffering from PAD will have the opportunity to receive this novel sirolimus drug coated balloon technology.  This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly," Dr Adams commented.    

"This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year R&D program to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the US FDA," added Jeffrey B. Jump, MedAlliance Chairman and CEO. "We are very pleased with the rapid level of sales growth we are experiencing in Europe, Asia and South America and very much look forward to entering the US market."

SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-Fistula indications.

In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomized controlled study comparing SELUTION SLR with any limus drug-eluting stent [DES]. This is the largest DEB study ever initiated and has the potential to change medical practice.

MedAlliance's DEB technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days1. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance's proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.

SELUTION SLR is available in Europe and all other countries where the CE Mark is recognized.

Media Contact:

Richard Kenyon  
rkenyon@medalliance.com  
+44 7831 569940

About MedAlliance

MedAlliance is a privately-owned medical technology company. It is headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and USA. MedAlliance specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For further information visit: www.medalliance.com

1. Drug concentration evident in MicroReservoirs and tissue – Data on file at M.A. Med Alliance SA

 

Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg
Photo: https://mma.prnewswire.com/media/1875120/MedAlliance_SELUTION.jpg

MedAlliance_Logo

More News by PR Newswire India

2022 Yidan Prize - world's highest accolade in education - awarded to Dr Linda Darling-Hammond and Professor Yongxin Zhu

Casio to Release Mid-Size G-SHOCK

CLIMATE CHANGE AND HEALTH INEQUITY A DEADLY MIX FOR THE MOST VULNERABLE: WORLD HEART FEDERATION

LyondellBasell Postpones Restart of Berre, France Cracker until Next Year

SI GROUP EXPANDS LUBRICANT ADDITIVE PORTFOLIO WITH NEW AMINIC ANTIOXIDANT

KEREN AVIDAR NAMED INX GLOBAL GENERAL COUNSEL

Asian Hall of Fame Announces Induction 2022

ViewSonic Expands its Gaming Monitor Line with the New OMNI Series for Casual Gamers

Fibocom Launches New Generation of 5G Sub-6GHz and mmWave Module FX170(W) Series Based on Snapdragon X65 5G Modem-RF System at MWC Las Vegas 2022

Himalaya Wellness Company Partners with NIMHANS to Launch Project SURAKSHA

Dr. Giovanni De Micheli Honored with 2022 Phil Kaufman Award Presented by ESD Alliance and IEEE CEDA

Dynata's Global Consumer Trends survey: 53% of people are struggling to afford basic needs; 67% have reduced spending to combat inflation

BellSoft Releases Alpaquita Cloud Native Platform for Java Developers

LCOE-centered, 600W+ module drives global PV market with four key competencies

ABILITY DIABETES GLOBAL - A Landmark RCT in the field of PCI for patients with DM, completes Enrolment

Bitget Ranks As The Top Crypto Derivatives Exchange With 0 Trading Fees

CRMNEXT features in Gartner® Magic Quadrant 2022 as 'Visionary' in Sales Force Automation technology

IBIS STYLES ENTERS THE METAVERSE WITH 2022 'OPEN TO CREATORS' VIRTUAL ART GALLERY & CONTEST - FEATURING DIGITAL CREATORS FROM AROUND THE WORLD

Former CEO of Tricentis and renowned testing industry veteran, Sandeep Johri joins LambdaTest's board

Trina Solar Demonstrates Commitment to India, Showcases Cutting Edge N-Type Module at REI Expo 2022

Lifestyle's new festive campaign inspires one to groove in style

ZTE endorses Catalyzing Electrification Accord

FPT Industrial announces the acquisition of a minority stake in Blue Energy Motors

Moonfare Expands Foothold to India opening Digital Private Market Investing Platform to eligible investors

Ideanomics' subsidiary Energica to provide electric motorcycles for the upcoming G20 Bali summit

DBS Bank India collaborates with HDFC ERGO and Atradius to provide Trade Credit Insurance solution to Tata Metaliks

AFFINIS helps organizations ease compliance with the Structured Digital Database requirements of SEBI

Daiichi Sankyo joins Startup Creasphere's Program Powered by Plug and Play

Handheld releases new Nautiz X81: An ultra-rugged 5G Android 12 handheld with a familiar feel

The Mindful Foundation brings courses from Oxford Mindfulness Foundation to India

UST Recognized for Human Resources Excellence Across Nine Categories at the 2022 Brandon Hall Awards

ScentAir Continues its Sustainability Initiatives to Enhance Immersive Sensory Experience

Sweden spellbinds travellers with new chilling audio story

Edvoy launches 'Refer a friend' programme as thank you to student advocates

Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

WinWire Has Earned the Modernization of Web Applications to Microsoft Azure Advanced Specialization

UNIVERSAL MUSIC INDIA ACQUIRES MAJORITY STAKE IN TM VENTURES, A LEADING INDIAN MUSIC & ENTERTAINMENT COMPANY

M&M'S® Welcomes First New Character in a Decade

Global Business Leaders Say Hybrid Cloud is Critical to Modernization, Yet Security, Skills and Compliance Concerns Impede Success

GLOBAL STANDARD OF CARE SIGNIFICANTLY REDUCED DUE TO MENTAL HEALTH OF HEALTHCARE WORKERS

Vieworks to Showcase Industrial Cameras and Lenses at VISION 2022

Eviation's Alice Achieves Milestone with First Flight of All-Electric Aircraft

SAUDI ARABIA IS THE FASTEST GROWING TOURISM DESTINATION IN THE G20

Internet sensation Khaby Lame announced as QNB Group's Official FIFA World Cup Qatar 2022™ Brand Ambassador

GIGABYTE Launches Z790 Series Motherboards Supporting Dual-Generation Intel Processors

Deltek Research to Unveil Top Federal Contracting Opportunities for 2023

ViewSonic Unveils Industry-First Foldable 135" All-in-One LED Display Solution Kit

NEOM Tech & Digital Company steps into the future as 'Tonomus'

Global Fab Equipment Spending Forecast to Reach All-Time High of Nearly $100 Billion in 2022, SEMI Reports

Kohler India celebrates their 10th Year of Pecha Kucha in New Delhi, India

U.S. Soy Sustainability Assurance Protocol (SSAP) Certificates Can Now Be Transferred

CP KELCO PARTNERS WITH EXOPOLYMER TO BRING NEXT-GENERATION FUNCTIONAL BIOPOLYMERS TO MARKET

Old Mission Selects Solace to Support Rapid Growth of Business through Event-Driven Architecture

GIGABYTE Launches Four AMD X670 Motherboards for New Ryzen 7000 Processors

SRK Knowledge Foundation announces transformational partnership with The Global Network for Zero

LyondellBasell Announces Organizational Changes

HarperCollins India presents HAPPILY INSURED: Your Guide to Understanding Insurance and Leading a Stress-Free Life by Kapil Mehta

Hisense Unveils Its FIFA World Cup Qatar 2022™ TVC "Perfect Match" Ahead of Tournament

The 2022 4th "My China Story" International Short Video Competition Award Ceremony was held in Hangzhou, Zhejiang

Light up the festive season with 'Sale Dhamaka' on MSI's laptop range

GLOBAL LEADERS, EXPERTS, AND CULTURAL ICONS CONVENE AT THE MILKEN INSTITUTE ASIA SUMMIT TO CELEBRATE A TRANSFORMED WORLD

Bank of Baroda rolls out 'Khushiyon ka Tyohaar' as the Festive Season begins

XCMG New Port Machinery's High-end Intelligent Industrial Development Project Base Launches Production

NATIONAL INSTITUTE FOR HEALTH AND CARE RESEARCH CONDUCTS A GLOBAL ANNUAL MEETING TO ADDRESS RESEARCH IN SURGERY IN INDIA

DEAKIN UNIVERSITY HUBS to be set up in India at OP Jindal Global University, Symbiosis International University and Chitkara University

TargEDys and Inoliva announce they have entered a distribution partnership to bring Satylia® to Turkey

Top 50 Start-ups Bringing Innovation to the Global Homes and Buildings Industry

How Healthcare Organizations Can Enhance a Holistic Patient and Member View by Improving Insights from Data

Tata AIA Life Fortune Guarantee Pension gets a powerful upgrade

PDRL aims to certify 10,000+ candidates on AeroMegh Platform in the Drone Industry by the year 2024

DAZN ACCELERATES GLOBAL GROWTH MOMENTUM WITH ACQUISITION OF ELEVEN GROUP BUSINESSES

GoingZero Big Diwali Sale: Up to 40% Discount And Free Shipping On Zero Waste Products

Slow-fashion brand FREECULTR becomes the official merchandise partner for FIFA 2022™

Purple Quarter Facilitates HCAH's CTO, Ex-DealShare Techie Onboarded

Ghodawat Consumer awarded - Fastest growing FMCG Company of 2022

Cine Star Cricket League launched with television and entertainment industry's Divas

ELLE FANNING IS THE AMBASSADOR OF FAME, PACO RABANNE'S NEW FEMININE FRAGRANCE

Saudi Data, AI Authority (SDAIA) and Ministry of Energy Partner with IBM to Accelerate Sustainability Initiatives in Saudi Arabia Using AI

Unstoppable Women of Web3 Launches New Education Streams

PNAS Partners with Straive for Production Services

MOBILEUM convenes the region's leading telecom operators at WEMEET ASIA 2022

Bizverse has officially become a Meta long-term strategic partnership

STL divests IDS as a part of its ongoing portfolio realignment

Frost & Sullivan Honors Tampa Electric Company and Warren, Simpson & Butler County Water Districts with Itron Excellence in Resourcefulness Awards

Mindray Showcases Hematology Innovations and Academic Achievements to the World at ISLH 2022

Deepak Chopra & Seva.Love Announce "ChopraVerse: House of Enlightenment," the Metaverse for Wellbeing in Collaboration with Utopia

MSC TO DEVELOP AIR CARGO SOLUTION IN RESPONSE TO MARKET DEMAND

Harpercollins is proud to announce the upcoming release of The Anarchist Cookbook: A Toolkit to Protest and Peaceful Resistance by Aakar Patel Illustrations by PenPencilDraw

Saudi Arabia launches Nusuk, an integrated digital platform, to facilitate pilgrim journeys for visitors from around the world

MEIL's wholly owned subsidiary MeghaGas, now MCGDPL, to execute City Gas Distribution

Yabx emerges as a leader in digital lending platforms at the top Global Fintech Awards

FII Institute reveals the world's top priority is the rising cost of living

All about IBSAT - One of the Top MBA Entrance Exams in India

MAPIC India 2022 honors India's most admired retail and tech innovators at the MAPIC India Retail Awards

Hasiru Dala Innovations joins forces with Satma CE to give immutable waste traceability from collection to final product made from waste

Bank of Baroda launches Baroda Tiranga Deposits

Alicon Castalloy Limited wins large, multi-year order from Jaguar Land Rover for eMobility Platform

mCaffeine's Biggest Body Care Launch Gets an Overwhelming Response from the Audience: 1 Consumer Subscribed Every 3 Seconds for the Launch

On World Lung Day, Alkem Laboratories pledge to spread awareness about lung diseases through its initiative 'The Healthy Lungs'

LONGi is to showcase its award-winning Hi-MO 5 Series at the Renewable Energy India Expo 2022, unveiling its new Hydrogen Business exclusively for Indian customers

LEXUS INDIA ANNOUNCES MENTORS FOR THE LEXUS DESIGN AWARD INDIA 2023

Mane Kancor CEO Geemon Korah hailed as one of the best CEO's in India

SVKM's NMIMS signs an MoU with HTWG Konstanz, Germany, for short study and research

Top HR Chiefs from TTK Prestige, Silicon Labs, Virtusa, Bureau Veritas at Woxsen's Global HR Leadership Conclave 2022

Mastercard expands decades-long football legacy through GUINNESS WORLD RECORDS™ title with Luis Figo

Soroco and Whatfix Announce Strategic Partnership

ElevenEs produces a prototype of the largest LFP battery cell in Europe

SHEIN CELEBRATED "ROCK THE RUNWAY: SHEIN FOR ALL", ITS FW22 FASHION SHOW

Huawei Hosts the 9th Global Rail Summit in Berlin

Campus With A Conscience hosts a-week long SDG festival

Woxsen University spearheading the internationalisation of higher education in the region through brand new initiatives

 
 
TRENDING TOPICS
 
 
CITY NEWS
MORE CITIES
 
 
INDIA WORLD ASIA
Uttarakhand CM congratulates Lt Gen Anil...
WBSSC scam: Partha, Arpita's judicial cu...
Sacrosanct duty of husband to maintain w...
Prohibition raid leaves Bihar police sta...
Mumbai: Lata Mangeshkar music college la...
Defence Minister visits frontline areas ...
More...    
 
 Top Stories
Navratri 2022: Morning arti perform... 
"We strive for a relationship with ... 
EAM Jaishankar assures US administr... 
J-K: 2 injured after blast in parke... 
Arrest warrant issued against produ... 
Delhi HC dismisses plea of Facebook... 
Afghan women face social, economic ... 
Delhi Police arrests shooters of Go...