Covidien, known for its peripheral guidewires, entered the pharmacomechanical thrombectomy (PMT) market about six months ago by acquiring Bacchus Vascular, makers of the Trellis-8 Peripheral Infusion System.
Covidien demonstrated the Trellis-8 at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
The Trellis-8 is an isolated thrombolysis catheter with two occluding balloons, drug infusion holes between the balloons, and mechanical drug dispersion capabilities. The pharmacomechanical combination enables physicians to provide focused treatment of thrombus within a targeted vessel.
Once the 0.035 guidewire is in place, the 8F Trellis-8 is deployed. The balloons are inflated to isolate the thrombus. An additional port contains the lysing agent. A vibrating wire also helps break up the clot, while an aspiration port sucks up any debris. A typical procedure takes about 20 minutes, depending on the size of the clot and patient characteristics.
Although the ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial, which will compare catheter-directed thrombolysis (CDT) to PMT in the treatment of iliofemoral DVT, will not be completed until approximately 2014, early experience with PMT in this indication is promising, according to the Millennium Research Group's report issued in July.
“Firms are hoping that results of this trial will clarify the association between rapid clot lysis and the prevention of post-thrombotic syndrome in patients with proximal DVT, as well as demonstrate how PMT may have lower bleeding risks compared with traditional CDT alone," said Darren Navarro, senior analyst at Millennium.
“The reduced lytic doses and shorter treatment times in the intensive care unit afforded by PMT make this procedure safer and more user-friendly for the physician, and more convenient for the patient when compared to standard CDT,” Navarro said.
The American College of Chest Physicians (ACCP) published last year revised clinical guidelines that call for physicians to use PMT for acute proximal DVT in conjunction with anticoagulation drug therapy.
The new venous thromboembolic disease guidelines represent an evolution from the previous ACCP standard which recommended the use of anticoagulation drug therapy alone for the treatment of DVT.