Funding Will Support Commercialization of Cagent Vascular's Serranator Alto
July 12, 2018—Cagent Vascular, a developer of angioplasty balloons using the company's serration technology, announced the completion of $11.87 million in Series B funding that will be used to scale manufacturing and initiate a limited launch of its first product, Serranator Alto. Further uses of proceeds include supporting development efforts to build upon existing confirmatory data, expanding indications, and receiving additional regulatory clearances.
The Serranator Alto device received United States FDA 510(k) clearance and European CE Mark approval in 2017. It is indicated for the treatment of diseased femoral and popliteal arteries, dysfunctional arteriovenous access grafts, and arteriovenous fistulas.
The next product in the Serranator family of percutaneous transluminal angioplasty serration balloon catheters will be Serranator Bass, for use in infrapopliteal arteries.
The Serranator is an angioplasty device with serrated metal strips embedded on a semicompliant balloon. The technology is designed to create multiple longitudinal lines of interrupted microserrations within the luminal surface to aid in arterial expansion resulting in predictable and controlled lumen gain.
The company advised that the Serranator Alto was evaluated in the above-the-knee PRELUDE study and performed well, especially in a subset of patients with severe calcium.
In Cagent Vascular's announcement, Mahmood K. Razavi, MD, commented, “The Serranator’s serration technology is unique in that it combines an effective vessel dilatation technology with a highly deliverable system on a single platform. In my experience, it is quite effective in calcified or highly fibrotic lesions where balloon angioplasty has historically fallen short.” Dr. Razavi is a vascular and interventional radiology specialist at St. Joseph Hospital in Orange, California.