February is American Heart Month—a time to take stock of our heart health and endeavor to improve it. According to the Centers for Disease Control and Prevention, cardiovascular diseases (CVD) are the leading cause of death for both men and women in the United States. In fact, heart disease is the number one killer of women, and since 1984, more women than men have died each year from heart disease.
While the mortality rate for men with CVD has declined for the past 30 years, the number of women who die from it has risen, and currently stands at nearly half a million per year. This is due, in part, to the fact that diagnostic and treatment methods have been geared towards men.
The American Heart Association reports that heart disease in women is more deadly than all forms of cancer, including breast cancer, combined. While 1 in 31 American women dies from breast cancer each year, 1 in 3 dies of heart disease.
In 2012, of the nearly 50 medical devices approved by FDA, a number directly impact of cardiovascular health. There were vascular stents, like Bolton Medical’s Relay Thoracic Stent-Graft used to repair aneurysms of the aorta, and Boston Scientific’s AXUS Express2 Paclitaxel-Eluting Coronary Stent used to treat sections of the coronary artery by permanently implanting a drug-eluting stent.
Other advances include HeartWare’s Ventricular Assist System used in patients waiting for a heart transplant. Edwards Lifesciences’ SAPIEN Transcatheter Heart Valve is transferred via balloon catheter to a damaged aortic valve in patients who cannot undergo open heart surgery to have a valve replaced.
Implantable defibrillators approved include: Cameron Health’s Sub cutaneous Implantable Defibrillator System that provides an electric shock to the heart to treat ventricular tachyarrhythmias in patients without symptomatic bradycardia, and a full line of Medtronic CRDM Cardiac Resynchronization Therapy Defibrillators, which are implantable cardioverter defibrillators that also deliver cardiac resynchronization therapy.
Although renal denervation, a catheter-based procedure in which the nerve endings in the renal arteries are ablated resulting in lowered blood pressure, was introduced a couple of years before by Medtronic, in 2012, four other manufacturers (ReCor Medical, Vessix Vascular, Inc., Covidien, and St. Jude Medical) saw their devices receive the European CE Mark approval.
Hopefully, at least some of these and all future devices will include an equal share of women in clinical trials.
On another note, I’m proud to announce that this issue will feature a new column, “Executive Outlook,” written by Steve Halasey, a well-known medical industry expert and former Editor of MX (Medical Executive) magazine. Currently, Steve is the Vice President of Programs for the Institute for Health Technology Studies (InHealth), the authoritative resource for knowledge and perspectives about the role of medical technology in advancing patient health care and quality of life. Executive Outlook will run in alternate months.
Cheers,
Beth G. Sisk
Editor
