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March 28, 2019updated 28 Mar 2022 6:51am

What loose coatings mean for medtech

A recent study published in the Journal of Cardiovascular Pathology concluded that there had been three deaths associated with catheter coatings becoming loose and spreading via the patient’s bloodstream.

By GlobalData Healthcare

Recent deaths associated with catheter coatings are indicative of a larger issue with coatings on medical devices, causing complications for patients undergoing procedures using said devices.

Catheter coatings

A recent study published in the Journal of Cardiovascular Pathology concluded that there had been three deaths associated with catheter coatings becoming loose and spreading via the patient’s bloodstream, damaging vital organs such as the heart, kidneys, and lungs. These deaths point toward a major issue within the coatings of medical devices, especially commoditised devices creating severe complications and even leading to death.

Catheters and needles are commoditised medical devices that are ubiquitous across most surgical procedures within cardiovascular and general surgery. Similarly, stents are utilised within specialised procedures such as endovascular operations and across general surgery procedures.

Future of catheters, needles and stents

Angioplasty and angiography are very common procedures with vascular stenting, while the majority of non-vascular stents are within urology and nephrology. These products are used across numerous surgical procedures.

According to GlobalData, the use of vascular stents is growing at a compound annual growth rate (CAGR) of 6.5% while the use of non-vascular stents is growing at a CAGR of 4%.

The three deaths associated with endovascular procedures are indicative of an issue with the coatings of such devices. Cardiovascular and urological procedures are becoming increasingly common with large patient pools.

Catheters, needles, and stents are relied upon within these markets. If manufacturers are not cognizant of this issue and take no action to rectify the coatings on these medical devices, these markets will be adversely affected. GlobalData expects that this will lead to more recalls in the near future as patient death tolls increase. Major manufacturers need to refocus their R&D efforts in order to better streamline products and prevent patient deaths.

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