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Figure 1: Scoreflex NC Scoring PTCA catheter with major section labels

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:  Scoreflex NC Scoring PTCA Catheter
PMA Applicant:  OrbusNeich Medical (Shenzhen) Co., Ltd.
Address:  No. 1 Jinkui Road, Futian Free Trade Zone, Shenzhen, 518038, China
Approval Date:   December 21, 2021
Approval Letter:  Link to Approval Letter

What is it? 

The Scoreflex NC Scoring PTCA Catheter is intended to open narrowed or blocked arteries in the heart with the use of a balloon catheter and a scoring wire (see Figure 1). 

How does it work? 

The Scoreflex NC Scoring PTCA Catheter is inserted through the blood vessels. Once at the treatment site of the blocked or narrowed artery of the heart, the balloon is used to reopen blocked or narrowed arteries while the wire (or scoring element), which is located on the outside of the balloon, applies a concentrated pressure to help open the hardened lesions (areas of abnormal tissue) in the arteries of the heart. The balloon is then deflated, and the catheter is removed from the blood vessels. 

When is it used? 

The Scoreflex NC Scoring PTCA Catheter is used when arteries in the heart are narrowed or blocked due to coronary artery disease

What will it accomplish? 

The Scoreflex NC Scoring Catheter will open a narrowed or blocked artery in the heart. In a clinical study, the Scoreflex NC Scoring PTCA Catheter was successfully used and normal blood flow in the heart was achieved without injury to the blood vessel 93.5% of the time (187 out of 200 patients).

When should it not be used? 

The Scoreflex NC Scoring PTCA Catheter should not be used in patients who:

  • Have an unprotected left main coronary artery
  • Have a coronary artery spasm in the absence of a significant stenosis (narrowing of the artery)

Additional information (including warnings, precautions, and adverse events):  

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