Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints.
The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers.
“I’m quite encouraged by the highly positive results demonstrated by the Surfacer System. I am eager for the system’s commercial approval and look forward to offering a reliable and repeatable solution to patients with varying occlusion types, halting the devastating impact of central venous occlusive disease,” SAVE-US study lead principal investigator Dr. Mahmood Razavi of Orange, Calif.’s St. Joseph Hospital said in a prepared statement.
The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later inked an EU distribution deal with Merit Medical (NSDQ:MMSI) that included an equity stake.
The Surfacer is designed to be threaded through the femoral vein up to and into blockages in the jugular, which acts as a stabilizer. The head of the catheter is then aligned via fluoroscopy with a target on the surface of the neck, and a needle guide is advanced through to the skin. A sheath is then inserted, the Surfacer retracted and a central venous catheter is attached to the sheath, the company said.
Of the 30 patients in the trial, 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer system, Bluegrass Vascular said. Central venous access was achieved in approximately 12 minutes on average despite a more complex patient population comprised largely of Type 3 and 4 occlusions.
“The Surfacer System passed the SAVE-US study with flying colors, confirming the system is a safe, viable option for achieving right-sided central venous access, preserving secondary central veins. This is a highly anticipated treatment that gives physicians a safe and effective alternative to other less efficacious treatments with higher complication rates. I am looking forward to its commercial approval and implementing it into my day-to-day practice,” study investigator Dr. Ehab Sorial of San Jose, Calif.’s Santa Clara Valley Medical Center said in prepared remarks.
“I am grateful to the excellent team of physicians who contributed to the SAVE-US study’s outstanding success. I am eager to achieve the next major milestone of U.S. regulatory approval and anticipate that this hugely valuable treatment will be available to physicians and their patients in 2020,” prez & CEO Gabriele Niederauer said in a press release.
In January, Bluegrass Vascular said that it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter.