A New Solution for

VASCULAR DISEASE

A New Solution For

VASCULAR DISEASE

End Stage Renal Disease (ESRD) Is A Large Problem in the US

  • Approximately 100,000 people begin dialysis each year – a treatment that costs approximately $90,000 per year per patient to treat

  • More than 661,000 Americans suffer from kidney failure – kidney diseases are the ninth leading cause of death in the US

  • ESRD Patients represent <1% of Medicare patients, but >7% of Medicare expenditures (total of $49.2B)

  • Nania, R., Medicare Extends Special Services to People With Kidney Failure, AARP, October, 2019
  • United States Renal Data System, 2020 USRDS Annual Report
An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.

(click image to enlarge)

An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.

End Stage Renal Disease (ESRD) Is A Large Problem in the US

  • Approximately 100,000 people begin dialysis each year – a treatment that costs approximately $90,000 per year per patient to treat

  • More than 661,000 Americans suffer from kidney failure – kidney diseases are the ninth leading cause of death in the US

  • ESRD Patients represent <1% of Medicare patients, but >7% of Medicare expenditures (total of $49.2B)

  • Nania, R., Medicare Extends Special Services to People With Kidney Failure, AARP, October, 2019
  • United States Renal Data System, 2020 USRDS Annual Report
An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.
An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.
An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.

Hemodialysis often requires surgically created pathways that connect a vein and artery, called arteriovenous fistulas (AV fistula) and arteriovenous grafts (AV grafts), to access the vascular system. Over time, the requirement for access can become more frequent, decreasing the intervals between hemodialysis interventions.

Due to repeated access, the AV fistula or AV graft might become damaged and a surgical revision or surgery might be performed. Additionally, blockages or narrowing of the blood vessels can occur, requiring a procedure using a balloon catheter to clear the diseased vessels.

Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1 (2).

Arterial Fistulas and Grafts

Over two million patients globally use hemodialysis to treat ESRD.1 The Hemodialysis procedure is where the blood is filtered out through a hemodialysis machine and then returns it to the body when the kidneys are unable to function.

Hemodialysis is the most common method of renal replacement therapy and most often performed after creating a mature AV access site. However, these AV access sites typically have high failure rates due to stenosis. Physicians are always searching for effective and durable treatment options of AV stenosis. PTA is the most common procedure to gain vascular access in an stenosed AV fistulas and grafts. Patency rates can be as low as 23% at 6 months in AVF’s and AVG’s.2  The FLEX Vessel Prep™ System offers a unique approach to opening stenosis with potentially less trauma that may yield longer lasting patency.

References:

  1. U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2014.
  2. Kitrou, P.M., Karnabatidis, D., Endovascular Treatment of Dysfunctional Vascular Access: From Fundamentals to an Algorithmic Approach, Endovascular Today Supplement, Fall 2019

Over two million patients globally use hemodialysis to treat ESRD.1 The Hemodialysis procedure is where the blood is filtered out through a hemodialysis machine and then returns it to the body when the kidneys are unable to function.

Hemodialysis is the most common method of renal replacement therapy and most often performed after creating a mature AV access site. However, these AV access sites typically have high failure rates due to stenosis. Physicians are always searching for effective and durable treatment options of AV stenosis. PTA is the most common procedure to gain vascular access in an stenosed AV fistulas and grafts. Patency rates can be as low as 23% at 6 months in AVF’s and AVG’s.2  The FLEX Vessel Prep™ System offers a unique approach to opening stenosis with potentially less trauma that may yield longer lasting patency.

References:

  1. U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2014.
  2. Kitrou, P.M., Karnabatidis, D., Endovascular Treatment of Dysfunctional Vascular Access: From Fundamentals to an Algorithmic Approach, Endovascular Today Supplement, Fall 2019

Arterial Fistulas and Grafts

An angiogram of a patient with ESRD with a severely occluded arteriovenous fistula.

Hemodialysis often requires surgically created pathways that connect a vein and artery, called arteriovenous fistulas (AV fistula) and arteriovenous grafts (AV grafts), to access the vascular system. Over time, the requirement for access can become more frequent, decreasing the intervals between hemodialysis interventions.

Due to repeated access, the AV fistula or AV graft might become damaged and a surgical revision or surgery might be performed. Additionally, blockages or narrowing of the blood vessels can occur, requiring a procedure using a balloon catheter to clear the diseased vessels.

Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1 (2).

VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.

VentureMed Group, Inc. is a member of Medical Alley

VentureMed Group, Inc. develops and markets innovative endovascular medical devices to solve unmet medical needs in the treatment of PAD and stenoses of AV fistulas and grafts.

VentureMed Group, Inc. is a member of Medical Alley