On of June 5, 2019, FDA grantes Breakthrough Device Designation to Acotec Scientific Co., Ltd for Litos® Drug Eluting Balloon catheter for treating below the knee lesions.
This is the first time in history that an interventional medical device developed in China has obtained the FDA's Breakthrough Device Designation. This nomination represents FDA's recognition in high level of clinical data for the Asian population submitted by Acotec and will also help to accelerate FDA approval process for Acotec.
At early LINC conference in Germany this year, Director Guo Wei from the General Hospital of the PLA announced the 6-month data of the Litos & Tulip DCB clinical trial for BTK lesions (AcoArt II), which is the first in prospective, multicentre,RCT study that investigates the efficacy and safety of DCB in treating BTK lesion in China.
The results of this trial fully demonstrated the safety and efficacy of Litos & Tulip® DCB in the treatment of BTK lesions.
What is the Breakthrough Devices Program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.