Spectranetics (NSDQ:SPNC) today released data from a late breaking clinical trial of its Bridge occlusion balloon designed to reduce blood loss due to superior vena cava tears during lead extraction procedures, touting a 100% survival rate amongst patients treated with the balloon.
The company presented 1-year clinical experience data from the study today at the Heart Rhythm Society’s 38th Annual Scientific Sessions.
The Colorado Springs, Colo.-based company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention. The study aimed to explore the early impact of the balloon on the management of SVC tears as well as survival outcomes for patients treated.
“By having a tool that can occlude the bleeding and reduce exsanguination, you have a more stable patient. You also have more time to do a better repair, and therefore have a better outcome,” study investigator Dr. Roger Carrillo of the University of Miami Hospital told MassDevice.com in an interview.
In the study, researchers evaluated 35 confirmed SVC tears and 33 non-SVC events, with 9 confirmed SVC patients being treated with the Bridge balloon and 26 without. Of the 9 treated with the balloon, all patients were discharged alive from the hospital. Only 50% of patients with SVC events who were not treated with the balloon survived the procedure, according to the study.
“From a clinical point of view, [the Bridge balloon] makes a procedure that was safe, safer. Therefore, more patients can benefit from this procedure. Patients who were indicated that were afraid or concerned about the possibility of the risks are able to undergo the procedure with a higher degree of safety,” Dr. Carrillo said. “Tens of thousands of patients aren’t being referred for this procedure when indicated because of the risk. So by making the safe procedure safer, not only do we have more surviving patients, we have more patients who are willing to undergo the procedure.”
Researchers noted that SVC tears in the study occurred in populations identified as having a higher risk for complications, including female patients, patients with ICDs and those with leads 9.7 years or older.
Carrillo said that from a clinical perspective, the research reinforced the need to adjust workflows to plan for possible balloon use before the procedure.
“The important take away from the study is we need to change the workflow at the time of the extraction to make sure there is a guide wire and sheath before we proceed with the extraction,” Carrillo said. “That way we can use the potential benefits of the balloon.”
The company won FDA clearance for the Bridge balloon last February, indicated to temporarily occlude vessels during cardiac lead extraction procedures. After 1 year of clearance, approximately 40% of physicians are using the balloon during lead extraction procedures, Carrillo said, but he’d like to see the number grow.
“After 1 years, 40% of physicians do this, but I would like all of them to do that. I’d like to see it done in all patients. By changing the workflow, we can then be able to apply the balloon, because if it is not applied, once a complication occurs, you cannot float the balloon or position the balloon appropriately,” Carrillo said.
