Intact Vascular has raised $20 million to bring its postangioplasty dissection repair device to market. New Enterprise Associates (NEA) and other firms put up the money to see Intact through premarket approval of the Tack Endovascular System.
Wayne, Pennsylvania-based Intact designed the system to facilitate the repair of the dissections that can occur following balloon angioplasty. The percutaneous transluminal angioplasty (PTA) procedures used to treat peripheral artery disease can cause damage to vessels of varying degrees of severity. In some cases, the damage—dissection—is severe enough to restrict blood flow.
Intact thinks its system can treat such damage. The system features an over-the-wire delivery device loaded with self-expanding implants. Once the device reaches the site of a dissection, it drops off an implant, which expands to fill the diameter of the vessel.
Management at Intact think the approach will stop further narrowing of the artery, cut stress on the arterial wall, reduce the risk of acute arterial occlusion and otherwise improve outcomes.
NEA, H.I.G. BioVentures and Quaker Partners share Intact’s belief in the device. The investors joined together to commit $20 million to the company. Intact is pocketing the first tranche of money now, with a second set to follow later this year.
The financing sets Intact up to advance a clinical development program designed to generate data to support FDA approval of Tack. Intact is running three trials. The most advanced of the trials, which finished enrolling patients 13 months ago, is assessing the use of Tack in combination with plain and BARD Lutonix drug-coated balloon angioplasty.