Verve Medical, Inc.CATEGORY
Medical Device, NVDP
Verve Medical, Inc.Website: https://vervemedical.wordpress.com/
Hypertension is a global problem affecting approximately 1 billion worldwide. 25% of Americans are hypertensive and are at an increased risk of heart attack, stroke, renal failure and impotence. The cost of hypertension to global medical budgets is $500 Billion.
Over 2 million people worldwide require renal replacement therapy to sustain life. More than 10 million people will die each year from untreated kidney failure. 50 % of all CKD that leads to ESRD kidney failure is caused by hypertension.
Dialysis Costs are in excess of $90,000 per year in the US. Kidney disease represent for more than 20% of all Medicare costs. Majority of the ESRD patients will die within 5 years.
Verve Medical, Inc. (VMI) has developed and proven the safety and efficacy of a device for treating and improving kidney and heart function for chronic kidney disease (CKD) and end stage renal disease (ESRD) patients.
VMI’s proprietary system consists of an ablation catheter and RF generator that delivers energy and ablates the nerves responsible for controlling sympathetic tone. The results are a reduction in blood pressure, reduction of medications and improvement in kidney and heart function.
Controlling CKD at stage 3-4 and not allowing the progression to ESRD represents an annual health care savings of greater than $130 billion. The total market opportunity for treating the stage 3-5 CKD patient is in excess of $90 billion. Third world countries will benefit from this low cost and simple procedure.
VMI’s initial focus is on the stage 5 or ESRD patient. Clinical studies have shown that disruption of the sympathetic nerves in this patient group will reduce medications, blood pressure, improve kidney, heart function as well as increasing life expectancy and overall quality of life.
Stage 3-4 CKD patients will then be the focus of VMI. Again, encouraging results from sympathetic nerve disruption includes increases in kidney function and reduction in BP.
Many companies have attempted to develop products for renal denervation and they all share the common approach of access via the renal artery. The VMI procedure is a transurethral urological approach, which is not dependent on the renal arteries nor does it involve the use of systemic contrast for imaging and device placement. This makes the VMI procedure ideal for CKD and ESRD patients with compromised vessels and kidneys that are not able to withstand systemic contrast.
VMI’s device is introduced into the renal pelvis of the kidney through the natural orifice of the urethra. This is the only technique that has access to the majority (over 80% afferent) of these nerves. The procedure can be done in an outpatient or office setting which represents a tremendous cost savings over traditional hospital and cath labs required for the competition.