- Strategy
- Payers
- AI
- Cybersecurity
- Device Development
- Studies/Published Research
- Ethics
- Regulatory
- Digital Biomarkers
- Data Science
- Companion Diagnostics
- Clinical Care
- Digital Therapeutics
- Academic Research
- Virtual Reality
- RWE
- Digital Endpoints
- Medical Devices (Class II and Class III)
- Commercialization
- Clinical Trials
- Drug-Device Combinations
- SaMD
- Remote Patient Monitoring
- Patient Engagement
- Profiles/Q&A
FDA Approves Medinol’s Drug-Eluting Coronary Stent System
The EluNIR-PERL drug-eluting stent is used for the treatment of coronary artery disease.
Medinol announced that its EluNIR-PERL drug-eluting stent (DES) received approval from FDA. The device is used in the treatment of coronary heart disease.
The design of the stent allows for more precise navigation and placement in complex anatomies.
In a press release, Medinol CEO Yoram Richter said, “We are pleased to bring technologies to the U.S. that focus both on benefit to patients as well as unique and meaningful advantages to surgeons, allowing for precise stent placement, shorter procedure times and reduced radiation exposure.”
In the same press release, CoSo Health CEO Jae Lee stated that CoSo would distribute the device.
"We are proud to distribute one of the world's best drug-eluting stents via our intuitive and easy-to-use SaaS+ platform, which reduces layers in the supply chain," Lee said.
SOURCE
(Oct 24 2023); CoSo Health; Medinol Receives FDA Approval for Next Generation EluNIR-PERL Drug-Eluting Coronary Stent System; https://www.prnewswire.com/news-releases/medinol-receives-fda-approval-for-next-generation-elunir-perl-drug-eluting-coronary-stent-system-301965041.html
