Structural Heart Disease

Structural heart diseases include any issues preventing normal cardiovascular function due to damage or alteration to the anatomical components of the heart. This is caused by aging, advanced atherosclerosis, calcification, tissue degeneration, congenital heart defects and heart failure. The most commonly treated areas are the heart valves, in particular the mitral and aortic valves. These can be replaced through open heart surgery or using cath lab-based transcatheter valves or repairs to eliminate regurgitation due to faulty valve leaflets. This includes transcatheter aortic valve replacement (TAVR). Other common procedures include left atrial appendage (LAA) occlusion and closing congenital holes in the heart, such as PFO and ASD. A growing area includes transcatheter mitral repair or replacement and transcatheter tricuspid valve repair and replacement.

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InterValve gets 510(k) clearance for catheter

The FDA granted 510(k) clearance to InterValve to market its V8 Aortic Valvuloplasty Balloon Catheter.

Preparing for the worst

As we approach the summer season of doomsday movies in all their cinematic gore-y, it may be no surprise that nuclear catastrophe enters into a few imaginations. But at the FDA, it is science and not science fiction that is under discussion as the agency reviews an animal study on Amgen’s leukocyte growth factors as a nuclear countermeasure. The FDA will discuss whether a human study is warranted on May 3. The Bloomberg article includes a link to the FDA backgrounder.

AHA/ASA website focuses on valvular disease

The American Heart Association/American Stroke Association (AHA/ASA) has launched a website to educate consumers about valvular disease.

CVRx gains full FDA approval for hypertension study

CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study.

Development & Growth of TAVR in the U.S.

Since the FDA’s approval of transcatheter aortic valve replacement (TAVR) in 2011, improvements and scientific evidence have continued to mount.

Sapien sales tick up but Edwards lowers outlook

Edwards Lifesciences reported an increase in quarterly sales of its transcatheter heart valves but lowered its outlook for 2013.

AMA steps up efforts to control hypertension

The American Medical Association (AMA) is taking aim at hypertension and prediabetes in a multiyear program designed to prevent cardiovascular disease and type 2 diabetes.

Panel explores workings of global TAVR registry

Representatives from the FDA, medical societies, registries and industry met April 22 in Silver Spring, Md., to discuss creation of an international registry for transcatheter aortic valve replacement (TAVR). The collaboration is the first step in an effort to develop a consortium of cardiovascular registries for broad-based analysis and surveillance of medical devices and clinical outcomes.

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