Commoditised medical devices are under the spotlight following three patient deaths and a product recall, says GlobalData.
Recent patient deaths associated with the use of catheters and the news in February that Cook Medical issued a recall for one lot of their Transsceptal Needles due to a manufacturing error could signal an issue with commoditised medical devices.
Atif Nawaz medical devices analyst at GlobalData said: “The Cook Medical recall on their Transsceptal Needle coupled with three deaths associated with the use of catheters during endovascular procedures, could indicate an issue with the coatings of commoditized medical devices. These events highlight a possible issue with medical device coatings dislodging and damaging vital organs such as the heart, kidneys and lungs.
“As cardiovascular and urological procedures are becoming increasingly common with large patient pools it is important that manufacturers of catheters, needles and stents maintain patient confidence in the safety of their products.
“Catheters, needles and stents are relied upon within these markets and manufacturers need to improve their R&D and quality control processes to prevent further recalls, patient deaths and maintain patient confidence with high volume devices.”
Angioplasty and Angiography are very common procedures with vascular stenting, whilst the majority of non-vascular stents are within the urology and nephrology space. According to GlobalData vascular stents are growing at a CAGR of 6.5% while non vascular stents are growing at a CAGR of 4%, globally.