The newest generation of defibrillators and devices for heart failure by the Boston Scientific Corporation (BSC), a leading innovator of medical solutions for over 30 years, has received an FDA approval on Tuesday, April 15.
"These newly approved devices continue the Boston Scientific history of industry-leading projected longevity and a six-year CRT-D warranty," the company said in a statement.
Among the FDA-approved are the DYNAGEN MINI and X4 devices, and the INOGEN MINI ICDs and X4 CRT-Ds devices.
BSC explained that the CRT-Ds and ICDs have been designed to treat patients who suffer from heart failure as well as to give protection to patients who are at risk of sudden cardiac death (SCD).
The American Heart Association explained that heart failure happens when the muscle of the heart fails to pump a sufficient amount of blood that the body needs for oxygen and blood. It also said the condition is a chronic and progressive one. It added that when there is loss of heart function, that's when SCD occurs.
SCD is a leading cause of deaths, accounting for about 400,000 cardiac arrests happening out of the hospital yearly in the U.S. It occurs suddenly and often without any warning.
The X4 CRT-Ds provides additional pacing preferences by 70 percent to efficiently address phrenic nerve stimulation and high capture thresholds together with the industry's biggest battery capacity.
Meanwhile, the MINI ICDs are the thinnest and smallest devices for heart failure in the world, providing comfort and treatment for patients with life-threatening arrhythmias of the heart. Volume-wise, these are smaller by as much as 20 percent as well as thinner as much as 24 percent as compared to other competing devices from varied manufacturers.
"The tiny size of the MINI ICD provides a real benefit to some patients, in particular those with a smaller frame," said Prof. Dr. Hans-Joachim Trappe from Bochum, Germany.
BSC executive vice president Joe Fitzgerald said that with these new devices, BSC now offers the finest range of medical solutions and options for patients at risk of SCD regardless of the need for cardiac resynchronization treatment. Fitzgerald is also the president of the Rhythm Management division at BSC.
"Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients," he said.