Health & Medicine
Abbott's Absorbable Heart Stent Wins FDA Approval
Johnson D
First Posted: Jul 08, 2016 04:19 AM EDT
The U.S. Food and Drug Administration said that they approved a stent by Abbott Laboratories that can be absorbed into the bloodstream after implant.
According to Reuters, the U.S. FDA approved the use of an absorbable heart stent called Absorb. Cardiologists say that the device shows a significant advancement in the treatment of coronary artery disease.
The stent, which was given the name Absorb, is already being sold in Europe and Asia. It is made of a plastic that is similar to dissolving sutures and give patients something to choose from besides metal stents that are currently used to open arteries cleared of blockages. It is also the only dissolving stent permitted to be used to treat coronary artery disease suffered by more than 15 million people in the United States. It is also still the primary cause of death around the world.
Tech Times reported that unlike the traditional stents, Absorb was designed to fully dissolve within three years of the procedure. The advantage of the stent is that it allows the blood vessel to go back to its original state without any metal implant. Mitchell Krucoff, a professor at Duke University Medical Center who has advised Abbott on Absorb explained that this approach will be very useful for patients whose coronary disease requires them to have multiple implants over the span of several decades.
"The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease," says Gregg Stone, chairman of the clinical trial program for the medical stent.
However, experts say that this stent should come with a warning. These experts claimed that the Absorb bioresorbable heart stent has the tendency to promote the formation of blood clots for some patients.
In the early 2000s, metal stents was popularly used to treat patients who suffered from heart attacks and chest pains caused by clogged arteries. Actually, these metal stents are still used by approximately 850,000 patients in the United States every year.
But, doctors, according to The Wall Street Journal have cut back on the use of metallic stents because of concerns for safety, had seen evidence that they are overused, and insurance cost-cutting.
A five-year study showed that patients who were treated with stent implants for chest pains recovered the same way as patients who received medications.
The company study, called Absorb III, found that 7.8 percent of patients treated with the absorbable stent suffered "a major cardiac adverse event," a rate that was considered "clinically comparable" to that of Abbott's drug-coated metal stent called Xience at 6.1 percent.
"We're going to roll this out commercially in a phased way, starting with the sites that have had experience with our clinical trials and proceeding from there," according to Charles Simonton, chief medical officer for Abbott's vascular business,
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First Posted: Jul 08, 2016 04:19 AM EDT
The U.S. Food and Drug Administration said that they approved a stent by Abbott Laboratories that can be absorbed into the bloodstream after implant.
According to Reuters, the U.S. FDA approved the use of an absorbable heart stent called Absorb. Cardiologists say that the device shows a significant advancement in the treatment of coronary artery disease.
The stent, which was given the name Absorb, is already being sold in Europe and Asia. It is made of a plastic that is similar to dissolving sutures and give patients something to choose from besides metal stents that are currently used to open arteries cleared of blockages. It is also the only dissolving stent permitted to be used to treat coronary artery disease suffered by more than 15 million people in the United States. It is also still the primary cause of death around the world.
Tech Times reported that unlike the traditional stents, Absorb was designed to fully dissolve within three years of the procedure. The advantage of the stent is that it allows the blood vessel to go back to its original state without any metal implant. Mitchell Krucoff, a professor at Duke University Medical Center who has advised Abbott on Absorb explained that this approach will be very useful for patients whose coronary disease requires them to have multiple implants over the span of several decades.
"The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease," says Gregg Stone, chairman of the clinical trial program for the medical stent.
However, experts say that this stent should come with a warning. These experts claimed that the Absorb bioresorbable heart stent has the tendency to promote the formation of blood clots for some patients.
In the early 2000s, metal stents was popularly used to treat patients who suffered from heart attacks and chest pains caused by clogged arteries. Actually, these metal stents are still used by approximately 850,000 patients in the United States every year.
But, doctors, according to The Wall Street Journal have cut back on the use of metallic stents because of concerns for safety, had seen evidence that they are overused, and insurance cost-cutting.
A five-year study showed that patients who were treated with stent implants for chest pains recovered the same way as patients who received medications.
The company study, called Absorb III, found that 7.8 percent of patients treated with the absorbable stent suffered "a major cardiac adverse event," a rate that was considered "clinically comparable" to that of Abbott's drug-coated metal stent called Xience at 6.1 percent.
"We're going to roll this out commercially in a phased way, starting with the sites that have had experience with our clinical trials and proceeding from there," according to Charles Simonton, chief medical officer for Abbott's vascular business,
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone