Breakthrough Device: Vairnew
Vairnew® paclitaxel-coated pulmonary artery balloon dilatation catheter
Feature
- Drug coated balloon
- Combined with drug treatment and mechanical expansion
Technological innovation
- Unique drug formulation and design for pulmonary stenosis
Certification Name: FDA Breakthrough Device Designation
Certification Number: Q241403
Fully adapted to different sizes of pulmonary artery structure
Breakthrough Device: Vairnew
On October 10, 2024, it has awarded the Breakthrough Device designation during the FDA's medical device review process for the treatment of patients with chronic thromboembolic pulmonary hypertension who are difficult to operate, or patients with residual/recurrent pulmonary hypertension after surgery, or patients with low risk/benefit ratio of pulmonary endarterectomy.
Bhmintbh Pulmonary Artery Balloon Dilatation Catheter
Feature
- Fast exchange design, excellent conveying performance
- Diameter 1.0-10.0 mm, designed for pulmonary arteries
- Combined with "Vairnew", it is used for predilation of pulmonary stenosis segment.
Indication
- Treatment of pulmonary stenosis
Technological innovation
- Ultra-high pressure balloon design, accurate expansion effect
Fully adapted to different sizes of pulmonary artery structure
Product Name: Vascular interventional surgery simulator
Application
- This device is specifically designed for the training and evaluation of vascular interventional of heart, brain, lung, and peripheral vascular.
ltems of training
- Manipulation of instruments such as catheter sheaths, balloon catheters，and guidewires.
- Simulation training for injection techniques and balloon expansion.
- Providing reference curves.
Technical advantages
- Real surgical images combined with visualization technology provide surgeons with a more accurate operating experience and help them quickly improve their surgical skills.
Vascular interventional surgery simulator