FDA staff reviewers' concerns about Abbott Vascular's mitral regurgitation repair device seem to have been dismissed by an FDA panel who recommended its approval
The FDA staff reviews think that Abbott's mitral valve repair device should not be approved. What other companies in this space hope to fare better?
Boston Scientific's Watchman device has attracted all manner of attention these past few days, but its chance of approval is now at 50/50, less so than before.
Signs of heart disease have been found in mummies from all over the world, reports the Lancet .
How nContact used its relationship with Xeridiem to overcome challenges and accelerate advancement of its product.
In the U.S., success of Edward Lifesciences transcatheter aortic valve replacement system depends on hospitals making more money per procedure through reduced hospital stays
Biotronik, the German medical device company, has won approval for a novel ICD. But will it win the hearts and minds of doctors?
The Food and Drug Administration’s Early Feasibility Medical Devices Clinical Studies program, a program meant to speed up the regulatory review process of innovative medical devices, has spawned its first graduate.
The Valentine's Day episode of the hit series “Grey's Anatomy” featured Dr. Cristina Yang (played by Sandra Oh) performing a heart procedure using a device known as The Parachute. The device, which is currently undergoing clinical trials in the United States, is a minimally-invasive, catheter-based treatment for heart failure. CardioKinetix, the company behind The Parachute, says the device partitions the coronary muscle damaged by a heart attack from the healthy, functional segments of the heart.
Mike Carrel also told MD+DI that the company’s current focus is on raising market awareness for its cardiac surgical ablation system for atrial fibrillation and explained that its net loss is all part of the plan.
Power Medical Interventions was founded to faciliate minimally invasive procedures. Similarly, MID could follow a similar path, by creating products that improve percutaneous and minimally invasive heart repair procedures like TAVR.
Edwards Lifesciences Corp. has won a recent patent suit in the U.S. Appeals Court against Medtronic, agreeing with an earlier ruling in which the Delaware Federal District Court found Medtronic for $73 million in damages. The Delaware court, however, dismissed Edwards’ attempt to block Medtronic from marketing the CoreValve in the United States. The Federal Circuit Court, however, advised that an injunction should be reconsidered. At issue is the infringement of United States Patent No. 5,411,552, which was issued May 2, 1995.
Imagine a future in which heart patients are implanted with multiple tiny sensors. “These sensors talk to each other within the body but there is a single point where the information is collected within the body and transmitted out,” says Elizabeth Hoff, vice president and general manager of Cardiac Connected Care at Medtronic. “That transmission likely will go to a cell phone which will then go to a monitoring center or an Internet site and someone will be watching that.”
In May, the Brookings Institute published a piece titled “How Mobile Devices are Transforming Healthcare.” Among the many topics mentioned in that report was a case study at Portsmouth Regional Hospital, which was able to cut the ER waiting times using mobile technology. Similarly, Medtronic has just launched a service to improve the treatment of patients with cardiac devices awaiting treatment in the ER or OR. The industry-first service, known as CareLink Express, allows healthcare facilities to work with device technical experts remotely.
Atherosclerosis is nothing less than a global epidemic. The condition leads to arthersclerotic cardiovascular disease, which is the cause of more than 50 million deaths around the world . Atherosclerosis itself occurs when fat, cholesterol, calcium, and other substances deposit on arterial walls to form plaque.