Case Study

Ablative Solutions

Drug/Device Combination Product - Invention through Life Cycle Management of Infusion Catheter for the Treatment of Hypertension.

The Challenge

The Challenge

Founded in 2011, Ablative Solutions, Inc. is a venture-backed company that developed I.P. for a Renal Denervation Device, but with limited resources and the need to move quickly, they came to REV·1 for the development of their combination product.

The Solution

The Solution

REV·1 initiated the engagement in November, 2011, with the development of a project plan to bring the device to clinical trials. REV·1 was charged with managing all aspects of the development of the Peregrine System™ Infusion Catheter.

“I outsource everything. So character is critical to me. Our goal was to build our device, test it and be acquired. When we decided REV.1 was our partner, they started the very next day, and every day they put skin in the game. They owned our project like it was theirs, they aren’t a fair-weather outsourcing company, they are always available and always listening. Their high-quality work and ability to problem-solve allowed us to get our life-saving product market-ready faster than we originally projected.”

Vartan Ghazarossian, CEO, Ablative Solutions

The Result

REV·1 delivered it as a “First In Man” device, then on to broader Clinical Trials, and 510(k) approval in March, 2014. The device received the CE Certificate of Authority in May, 2015. Ablative Solutions continues to work with REV·1 today, developing their second-generation device.

“REV.1 created a robust medical device that met all testing requirements ahead of schedule, bringing us a market-ready product more quickly than we could have imagined.”

Vartan Ghazarossian, CEO, Ablative Solutions

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