Take a good look at the image to the left. Could it be the latest high tech cardio machine from a swanky new-age gym, a computerized gold club that provides instant feedback on your swing or perhaps a revolutionary whole-house Bluetooth speaker system?
No, no and no!
What you are looking at, ladies and gentlemen, is a revolutionary new device for the treatment of high blood pressure. Yes, that’s right. Not monitoring, but treatment.
The Vessix Vascular V2 Renal Denervation System™ is the result of a collaboration between two California based companies – Vessix Vascular, Inc., a pre-revenue stage medical technology company, and product innovation consultancy Karten Design.
This new technology has the potential to help the 68 million (one in three) adults in the United States who suffer from hypertension — a condition that is more common than cancer, diabetes, and coronary artery disease combined.
Hypertension is a major risk factor for heart disease, stroke, congestive heart failure, and kidney disease and was listed as a primary or contributing cause of death for more than 347,000 Americans in 2008.
In 2010, high blood pressure cost the United States $93.5 billion in health care services, medications, and missed days of work
Today, anti-hypertensive drugs are the primary treatment for hypertension. But despite the widespread use of drugs, only about half of hypertensive patients around the world are well controlled, even when multiple medications are taken at optimal dosages.
This new device could potentially change all that.
In as little as 30 seconds per artery, the Vessix V2 System performs a one-time minimally invasive catheter-based percutaneous procedure that has been shown to significantly reduce blood pressure.
Using a short blast of radiofrequency (RF) energy to disable the sympathetic nerves surrounding the arteries leading to the kidneys, in a procedure called renal denervation.
TV’s Dr. Mehmet Oz has called this treatment “a profound game changer.”
Hyperactivity of the renal nerves leads to uncontrolled high blood pressure, also called resistant hypertension. According to the American Heart Association, a 5 mm Hg reduction in systolic blood pressure results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in overall mortality. In clinical studies, renal denervation has shown to reduce systolic blood pressure by as much as 20%.
Vessix’s patented V2 Catheter delivers precise temperature-controlled energy to both renal arteries in 60 seconds, while the only other competitively marketed Renal Denervation system takes 50-60 minutes. The rapidity of the V2’s treatment promises to reduce patient discomfort as well as exposure to radiation for both the patient and the interventional cardiologist performing the procedure.
“I wanted a design that immediately communicates that there’s something new and exciting going on — even before I explain how the product works,” said Vessix CEO Raymond Cohen. “The goal was to have the product look faster, sexier, and more advanced than any other piece of equipment found in the hospital.”
To ensure the system’s design supports the physician’s natural workflow in the catherization lab, Karten Design worked with Vessix during the early phases of product definition, visiting hospital cath labs and interviewing doctors to determine the system’s ideal usage. Karten Design researchers and designers learned about the human factors surrounding a catheter-based procedure, including visibility, access, and sterility.
Vessix began a 64-patient human clinical in February in Europe. The first patient treated was 39 years old with pre-treatment blood pressure readings of 174/114 despite taking four anti-hypertensive medications. The second patient was 44 years old with a blood pressure of 168/106 despite taking six anti-hypertensive medications. The 10 center study will follow patients for 24 months following their renal denervation procedure.
Although the system has already received a CE Mark approval for the treatment of hypertension, it is not yet available in the US.
Assuming all goes well with the clinical studies, we look forward to the day it is.