Graftcath Inc is an early-stage company developing a next-generation approach to vascular access that has the potential to significantly decrease the graft failure rate in patients undergoing haemodialysis treatment. Speaking at the VEITH Symposium (17-20 November 2005, New York), Dr Marc Glickman, Eastern Virginia Medical, said that early results from a Phase III trial of Graftcath’s new graft technology were encouraging, which has tempted Boston Scientific into making an investment.
The Graftcath Vascular Access System (GVAS) is a synthetic material graft for arteriovenous access. “It connects a PTFE graft to a [19F] silicon catheter, using a titanium connector,” Glickman told Vascular News. This change to the fundamental design means that turbulence in the bloodflow should be substantially reduced, thus decreasing intimal hyperplasia and eliminating venous anastomosis; removing the causes of most graft failures.
This Phase III trial, of which Glickman is the principal investigator, is a prospective, randomized, multi-center study comparing Graftcath to a standard ePTFE graft in hemodialysis patients. “The aim is to recruit a total of 138 patients,” he said. “So far we’ve had 38 randomized to either normal graft or Graftcath.” The data presented at Veith covered the first 19 patients recruited: nine male and ten female. To be included in the trial, subjects must be over 21 years of age and have their right side available for implant. Those with a body mass index above 40, whose right internal jugular vein was less than 10mm, or who had an occluded internal jugular on either side of their body were excluded. The primary endpoint was equivalence to graft secondary patency. The procedure involves percutaneously inserting a catheter into the internal jugular under ultrasound guidance, then tunnelling the catheter into the infraclavicular area and connecting it to the ePTFE graft, before tunnelling the graft to the brachial artery.
Of the 19 patients so far treated, ten have received GVAS. Two of those ten have lost primary patency, compared to three of nine in the control group. Loss of secondary patency has occurred in one patient from either group, and there has been no bacteremia. In terms of adverse events, the control group has seen one case of infection and one of sepsis, while in the active group there have been two cases of steal, where relatively intact vessels dilate, altering flow. With simple implantation and few complications, the prospects for GVAS look good.
Glickman estimated that it would take until the end of 2006 to finish the trial, which would then be used as a submission to the FDA for approval. He revealed that he had submitted a paper to the Vascular Access Society meeting in Phoenix, Arizona (18-19 May, 2006), when he should be able to present further updates.
Graftcath was founded in 1998 and is based in Eden Prairie, Minnesota. “It’s a small company, this is its first product,” said Glickman. The trial started in January 2005, and since December has been sponsored by Boston Scientific. Ever on the acquisition trail, Boston may well look to gain access to GVAS, should it be successful. “It’s Boston’s standard model. If they follow previous milestones then I think they will,” he concluded.