PTA BALLOON CATHETER MARKET ANALYSIS

PTA Balloon Catheter Market, by Material Type (Polyurethane, Nylon), by Application (Coronary Artery Disease and Peripheral Vascular Disease), by End User (Hospitals, Ambulatory Surgical Centers, and Others(Specialist Clinics)), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030

Published In : Sep 2022
Code : CMI2815
Pages :178
Formats :
Excel and PDF
Industry : Medical Devices

Market Challenges And Opportunities

Increasing number of product recall by the U.S. FDA (Food and Drug Administration)

Global PTA Balloon Catheter Market: Restraint

PTA balloon catheters are regulated by the U.S. Food and Drug Administration in the U.S. The Food and Drug Administration (FDA), the U.S. agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Hence, product recall by U.S. FDA is expected to hamper the market growth.

For instance, in October 2020, the U.S. Food and Administration recalled Class 2 device conquest PTA balloon dilatation catheter offered by Bard Peripheral Vascular Inc., a manufacturer of medical equipments. The product was recalled due to packing issue. The labelling states that the balloon size is 6mm x 40mm, however included a 5mm x 40mm balloon. Dilation catheter was packaged with the wrong size balloon.

In June 2019, Cook Medical’s, a medical device company, product balloon catheter used for percutaneous transluminal angioplasty was recalled by the U.S. FDA. MedWatch, the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program, reported complaints such as the surgery may be delayed if the balloon burst below the rated burst pressure, requiring another intervention.