September is Peripheral Artery Disease (PAD) Awareness Month, according to the American Heart Association (AHA). And with good reason, too: While most people are familiar with the big-name heart problems such as cardiac arrest and congestive heart failure, PAD is often overlooked. Even though this cardiovascular disease affects approximately 8 to 12 million people in the U.S., it is frequently mistaken for other health problems and often goes undiagnosed by physicians.
PAD occurs when narrowed or blocked arteries reduce blood flow to the legs and feet. Patients experience leg pain, tiredness, and cramping in the leg or hip muscles. If left untreated, PAD can lead to gangrene and amputation. PAD may be a warning sign of atherosclerosis, and according to the AHA, patients with PAD have four to five times the risk of heart attack or stroke.
Lifestyle changes such as diet and medication work for many PAD patients, but a minority will require surgery. Patients may undergo a balloon angioplasty, which can cause arterial dissection and necessitate another procedure to implant a stent. Or, in more severe cases, a bypass may be needed. A number of biotechnology companies are developing alternative treatments that could cost less and be just as effective as conventional angioplasty or bypass surgery. On Tuesday, Israeli biotech Pluristem Therapeutics (PSTI) announced that, in Phase I clinical trials, its placenta-derived stem cell therapy demonstrated safety and efficacy in patients with end-stage PAD. Reuters reports that patients experienced improvement in bloodstream, pain and quality of life for six months following a 20-minute session of injections. An estimated 2.5 million patients in the U.S. suffer from end-stage PAD, and insurance companies pay about $10 billion per year to treat them. Pluristem estimates that it can reduce reimbursement costs of insurance companies by approximately 50 percent.
Another company that specializes in treating PAD is Cardiovascular Systems, Inc. (CSII). The Company’s Diamondback 360° system utilizes a minimally invasive catheter designed to sand away the plaque that builds up in peripheral arteries, while preserving healthy arterial tissue, providing an alternative to surgery or amputation. The system was approved by the U.S. Food and Drug Administration in 2007.
Minnow Medical’s Peripheral Vascular System uses radiofrequency energy, delivered through electrodes on the surface of a balloon catheter, to reduce plaque deposits and improve blood flow within the artery. The treatment is performed during a brief endovascular procedure. The device has the CE Mark in Europe but is not yet approved in the U.S.
Other companies working in this space include TriReme Medical, Dimera Inc., and Cardiomind. Arterial Remodeling Technologies is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty.
To learn more about PAD, Medical News Today reports that the Society for Vascular Medicine (SVM) has gathered information on PAD in recognition of PAD Awareness Month. The SVM Interactive Case Study of the Month for September also focuses on PAD.