The U.S. Food and Drugs Administration (FDA) is going to meet on Tuesday to whether approve or disapprove Abbott’s new dissolving stent.
Arteries are blood vessels that carry blood all around the body but sometimes, the flow of blood is interrupted which causes great harm to the human body. On those cases, doctors suggest a procedure called percutaneous coronary intervention or PCI. Surgeons insert a metal tube coated with drugs to treat narrow or blocked arteries to restore the blood flow. These metal tubes are called stents.
Absorb III is a new stent created by Abbott. The device is made of a material similar to those of dissolving stitches. The idea is that after a period of time, the plastic tube treats the artery and then dissolves.
The concept has been praised by many specialists. The implant disappearing allows the blood vessel to recover natural functionality after healing. In addition, if the doctors deem a second intervention necessary, they can work from scratch without having to remove a metal stent.
However, people are not sure if this implant is good
The FDA asked for the advice of specialists in the area. They will complement the agency’s staff on Tuesday. Some of the physicians ask the committee to make special emphasis on patients that have risk factors, such as diabetes.
Some of the reports say that there are more cases of heart attacks after using Absorb III than with company’s previous metal stent. However, the difference is dim and the company say that these numbers will improve with time.
“These results are from physicians using a new therapy for the first time. Consequently, we expect them to improve with time and experience,” said Abbott spokesman Jonathon Hamilton.
The product is already available in 100 countries and if the FDA approves it in The United States, the company expects for it to hold 5% of the current stent market.
Source: Reuters