iCHOR Case Study with NAMSA

Virtual Vascular Device Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent

Research Challenge

Peripheral Arterial Disease (PAD) is a condition that produces arterial fatty deposits and narrowed blood vessels, resulting in restricted blood flow to the arms, kidneys, stomach and most commonly, the legs. Worldwide, 14+ million people suffer from PAD with the most severe forms diagnosed as Acute Limb Ischemia (ALI) and Critical Limb Ischemia (CLI), both underserved disease states with significant morbidity and mortality rates. In the U.S. alone, over 2 million people have been diagnosed with Limb Ischemia(s), with the prevalence expected to reach 3.5 million in the coming year4.

Coupled with the high number of Limb Ischemia complications are those that result from current treatments, delivered through drug therapy or surgical intervention—both essentially unchanged for the last 30 years. With surgical treatment, patients run the risk of bleeding and infection, while also incurring the high cost of surgical procedures and required ICU hospitalization stays. Drug delivery options also present a high financial burden to patients due to increasing pharmaceutical costs.

Observing the need for a cost-effective, yet proven, therapy for Limb Ischemias, ICHOR sought to introduce the ICHOR Panacea Vascular Embolectomy Catheter System—a non-surgical, non-drug delivery treatment that:

  • Reduces ICU stays
  • Decreases patient healthcare costs
  • Improves patient outcomes
  • Advances overall healthcare economics
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