On Feb. 3, Christopher Allen, MD, a cardiologist with St. Anthony’s Heart Specialty Associates in St. Louis, became the first physician in the Missouri metro area to use Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries of the upper leg.
That day also marked the first time the newly FDA-approved treatment became available. The patient: Jackie Gallino of South County, Mo., who had developed an ulcer in her leg because of a lack of blood flow, prompted by a significant blockage of plaque at an inflexion point.
“We chose Jackie for this new treatment because of the location of the blockage,” said Allen. “A regular stent wouldn’t have worked well for her in reopening this artery.”
One thousand miles away, on March 2 at Largo Medical Center in Largo, Fla., Chris Wagner checked in at 6 am for a similar procedure. For nine years, he’d suffered from PAD, and was enthusiastic the promising new procedure would significantly reduce the risk of reinterventions in PAD. By 5 pm, the successful procedure completed, Wagner was headed home with a big smile on his face.
“Now I’m in no pain,” said Wagner, 80. “I can walk up and down 17 stairs with no problem – and I don’t have stop.”
For the procedure, Merrill Krolick, DO, an interventional cardiologist at the Tampa-area hospital, also used Medtronic’s IN.PACT Admiral DCB. Krolick is the second doctor on the Florida West Coast to perform the procedure.
“Of all the technologies out now, Medtronic’s drug-coated balloon has the lowest incidence of comeback rates within a year at 2.4 percent, compared to 20.6 percent treated with percutaneous transluminal angioplasty,” said Krolick. “That’s the home run.”
Exceptionally positive clinical data on Medtronic’s solution, including study results and comeback rates, were revealed from the pivotal IN.PACT SFA Trial at the Vascular Interventions Advances (VIVA) annual conference last November.
Medronic’s DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularization (CD-TLR) rate ever reported for an interventional treatment of PAD in the superficial femoral artery (SFA). The IN.PACT Admiral has proven effective in maintaining patency of the arterial lumen after one year in a trial, compared with traditional percutaneous transluminal angioplasty.
Data also revealed the highest reported rates of primary patency, which measures sustained restoration of adequate blood flow through the treated segment of the artery. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8 percent sustained restoration of blood flow in the DCB group, compared to 66.8 percent for the percutaneous transluminal angioplasty (PTA) group. Using the trial’s protocol definition, primary patency assessed at 12 months of follow-up was 82.2 percent for the DCB group, and 52.4 percent for the PTA group.
“This is the best balloon technology out that has better results than conventional balloon angioplasty,” said Krolick. “Save the metal for a later time. Arteries don’t like metal.”
During the IN.PACT Admiral DCB procedure, the balloon is inflated and emits paclitaxel, an antiproliferative medication. The inflated balloon pushes plaque away to create a channel for blood flow; the medication on the balloon surface is absorbed into the artery wall. The balloon is then removed with only the medication left behind. The procedure is usually done on an outpatient basis.
“Not only does this balloon reopen the affected artery, it delivers a drug designed to keep the artery from narrowing again by working to prevent scar tissue from forming,” said Allen.
Other key features of Medtronic’s DCB: the highest rate of restored blood flow in the treated artery, a minimized need for durable implants that carry a risk of fracture in the vessel, and an exceptional safety profile. Sizes range from 4-7 mm, and lengths of 40, 60, 80, and 120 mm.
Studies also show that a medication to the artery wall, as done with these balloons, helps keep the artery open longer than many other procedures and therapies available, and is more effective than stents at keeping the artery open long-term, while also reducing pain and downtime. The device has been cleared in Europe since 2009 and has already been used in approximately 100,000 patients.
LINKS:
Medtronic’s IN.PACT Admiral drug-coated balloon (DCB)
Vascular Interventions Advances (VIVA)
