Significant technological advancements are being made in medicine all the time, but they often come in waves, particularly when competing companies are racing to create solutions to a common problem. At present, a wave of biotech innovation appears to be targeting the hemodialysis. Israeli biotech firm, Laminate Medical Technologies, just announced on Friday that it launched its Stateside, FDA-approved trial for a new device designed for patients in need of vascular access for hemodialysis, a device that investors have already been watching closely. Concurrently, Bluegrass Vascular Technologies announced a day earlier that it also launched a critical trial for its so-called "inside-out" catheter that aims to serve the same purpose.

Laminate designed VasQ to be a sort of artificial blood vessel that can be surgically implanted in a patient who needs arteriovenous fistulas. It's one method of creating vascular access for hemodialysis. VasQ was made originally for kidney failure patients; it lends outside support to mitigate fistula collapse. That support also regulates flow inherently, though, because it constricts the fistula and superimposes upon it the most efficient shape for the vessel. The device also safeguards the perianastomotic vein from wall tension, inordinate pressure, and volatile flow rates according to Laminate's official press release.

The study has only just begun since it's ultimately a two-year, prospective, multi-site trial. It involves 129 different participating patients who all need brachiocephalic fistulas to basically be made for them. Researchers want to analyze how well the device works for these patients, but they also want to look for any other criteria that should determine eligibility for the trial like, perhaps, having blood vessel anatomy that's close enough to being correct to sustain the use of the device. Other examples might be preexisting conditions or medical history; patients may have co-morbidities pertinent enough to require that they do not participate in the trial.

This is biotechnology with a very common and universal purpose, and its efficacy has been put to the test already thanks to Drs. Paul Orland and Jason Burgess of the Carolinas Medical Center-Mercy based in Charlotte, North Carolina. "We are excited to be the first site that enrolled patients in the US," Burgess said in the press release. "The device was easy to implant and I am happy with the surgical results. We are looking forward to evaluating the device's long-term effect." Orland also made part of the statement, speaking to the efficacy of VasQ itself. "The device was easy to handle and I was very happy with the postoperative results. This new technology is targeting the major problems of [arteriovenous fistulas]: maturation and long-term longevity of the fistula," Orland expounded.

Laminate's official statement also said that the main objectives for establishing the effectiveness of VasQ in this trial are going to be primary patency rates around the six-month milestone after having fabricated the fistula, and researchers will follow up with patients at the two-year mark thereafter. "The launch of this pivotal study marks an important step forward for VasQ in the US market and a promising milestone for patients with kidney failure. We were excited to see the high level of interest and support from our partner sites when we offered them to participate in the study," Tammy Gilon said, speaking as CEO of Laminate Medical Technologies.

Bluegrass Vascular Technologies, on the other hand, is an American company that opted for a different approach. In contrast with VasQ, Bluegrass's Surfacer is meant to make the jugular accessible as a means of restoring central venous access during hemodialysis. It's not a matter of direct competition with Laminate because it targets patients whose neck veins are obstructed. In essence, it's a stabilizer for jugular veins obstructed by blockages, and it reaches them by threading up through the femoral vein. The catheter head is lined up with its target using fluoroscopy for that process, and a needle guide passes through the skin as an extra aid in that regard.

Procedurally speaking, that's when the physician inserts a sheath, retracts the Surfacer with the central venous catheter attached to said sheath. The official statement that Bluegrass made a day before Laminate announced a 30-patient study called the Save-US trial, which qualifies as an exemption study for analyzing how safe this investigational device is, as well as how effective it is. The study has yet to actually gain FDA approval thus far, though. "It is exciting to be on the forefront of hemodialysis care and provide life-saving solutions that improve patient outcomes while reducing costs. We look forward to treating patients in the Save-U.S. pivotal trial and supporting our ongoing commercialization efforts in Europe," according to Bluegrass CEO Gabriele Niederauer.

The company's statement mentioned that the earliest participants were admitted into the study at St. Joseph Hospital based in Orange, California as well as Houston Methodist Hospital in Texas. "Central venous obstruction is a serious disease that often causes a domino effect of vascular destruction, leaving hemodialysis patients and their physicians with limited options," according to Mahmood Razavi, a physician at St. Joseph. "The Surfacer system has the potential to change the standard of care by offering a new strategy that allows reliable and repeated access to the right internal jugular vein, the optimal location for catheter placement."

[researchpaper 리서치페이퍼=​Cedric Dent 기자]