One of the world’s largest medical technology, services and solutions companies, Medtronic plc MDT , announced the first patient enrollment under its IN.PACT AV Access Drug-Coated Balloon (DCB) study for patients with end-stage renal disease (ESRD).
Notably, the U.S. Food and Drug Administration (FDA) allowed the investigational device exemption (IDE) study to evaluate the safety and usefulness of IN.PACT AV Access DCB to treat failing arteriovenous (AV) fistulas in ESRD patients. This study will extend for up to two years at approximately 30 sites in the U.S., Japan and New Zealand.
This study has been designed to provide advanced clinical options for patients with restricted AV access. According to the company, DCBs are supported by clinical evidence in patients with peripheral artery disease (PAD) in the upper leg. Management is hopeful that this study will provide data to support the DCB’s use to improve patency and reduce the need for repeat interventions in AV access sites for patients on dialysis. The primary efficacy endpoint is patency of dialysis fistulas over six months while the primary safety endpoint is serious adverse events over 30 days.
Maintaining patency at AV access sites for dialysis patients is a challenge. The advancement of this study demonstrates the company’s sheer commitment to address challenging lesions and improve care for patients with ESRD. While the market for end-stage renal disease therapy is expanding rapidly, we find Medtronic’s focus on strengthening its foothold in this niche area to be strategic.
According to transparency market research , the global peripheral vascular devices market is expected to grow from $4.8 billion in 2011 to $7.8 billion by 2018. It also states that the global peripheral vascular devices market is expected to expand at a 7.10% CAGR during the 2012 to 2018 period.
Also, a report published by Market Data Forecast states that the peripheral vascular…