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FDA OKs IN.PACT™ Admiral™ Drug Coated Balloons of 200mm and 250mm Lengths
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IN.PACT™ Admiral™ Drug-Coated Balloon |
June 23, 2018 -- Angioplasty began over a half century ago not in the coronaries, but with the treatment of peripheral artery disease. It was a radiologist, Dr. Charles Dotter, at Oregon Health Sciences University in Portland who not only coined the term "angioplasty," but on January 16, 1964, performed the first procedure using his relatively crude overlapping catheter system to push through a blockage in the superficial femoral artery of an 82-year-old woman who was scheduled for but had refused amputation. The procedure was successful and amputation was avoided.
In the interim, of course, the equipment for opening up blockages in both the peripheral vessels and the coronary arteries became increasingly sophisticated: first balloons, then stents, then drug-eluting stents, along with a host of specialized catheters that performed atherectomy (removal of plaque), etc. Oddly enough, angioplasty was more successful as a treatment modality in the coronary arteries than in the leg. Plain Old Balloon Angioplasty (POBA) worked, but had a relatively high rate of reintervention. Drug-eluting stents definitely improved on these outcomes, but sometimes were subject to fracture. Also lesions in the superficial femoral artery tended to be long, and very long stents were not efficacious.
Enter the Drug-Coated Balloon (DCB) - coated with a drug (usually paclitaxel) that would suppress new tissue growth which might re-block the artery, but made of a material engineered to release the drug into the arterial wall so as to remain in effect after the balloon is withdrawn. A number of iterations and models of DCBs currently are being manufactured by several device companies: both the Lutonix by C. R. Bard and the IN.PACT by Medtronic have been approved for use in the U.S. by the FDA, and there is a spectrum of other devices available in Europe and in development by most of the major device manufacturers (Abbott, Boston Scientific, etc.).
To date, no large randomized controlled trial has measured the various DCB models against each other or against drug-eluting stents, but recently the two-year results of Medtronic's IN.PACT Global Study were published. It is the largest DCB registry to date with the longest follow-up. You can read the study and accompanying editorial in the May Issue of JACC: Cardiovascular Interventions (links in the right-hand column).
A subset of this registry analyzed very long lesions of over 180mm (7 inches), including cases of in-stent restenosis (ISR) and chronic total occlusions (CTO). The one-year results showed patency of 89.1% and clinically-driven target lesion revascularization at 7.1% (the CD-TLR was adjudicated by an independent panel, so the necessity of re-intervening was not just a matter of the operating physician's opinion). As a result of these findings, in April the FDA approved the IN.PACT DCB for treatment of long lesions. And last week, the FDA approved two new long length IN.PACT balloons (200mm and 250mm) that will become an important part of the armamentarium, implementing the April long lesion approval.
As indicated, the whole field of DCBs is rapidly expanding with other devices and more studies, but the results are very promising in the peripheral vessels and may eventually have a role in treating in-stent restenosis in the coronaries.
For more information specifically about the new IN.PACT DCB sizes, last week's press release from Medtronic follows:
Medtronic Receives FDA Approval for 200mm & 250mm
IN.PACT™ Admiral™ Drug Coated Balloons
New, Extended Balloon Lengths Enable Physicians to Efficiently Treat Long SFA Lesions
June 15, 2018 -- Dublin -- Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of the IN.PACT™ Admiral™ Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
Dr. Gary Ansel |
"As SFA disease progresses, we tend to see patients present with longer, more complex lesions. As a result, these lesions become incredibly challenging to treat and often require interventions with multiple technologies to effectively treat the entire segment," said Gary Ansel, M.D., system medical director for Vascular Services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio. "The approval of the IN.PACT Admiral 200mm and 250mm balloons provides physicians with a solution to treat these long, complex lesions with fewer devices, potentially leading to shorter procedure times and reduced procedural cost."
Complex lesions, including those over 150mm, are commonly encountered in clinical practice and remain a significant treatment challenge for physicians. In April of this year, IN.PACT Admiral received approval to treat SFA lesions up to 360mm in length. Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion (CTO) groups with lesion lengths >180mm. Across these groups, a total of 227 subjects with mean lesion lengths of 28.7 ± 7.1 cm were analyzed. Data showed a one-year patency rate of 89.1 percent by Kaplan Meier estimate at day 360, and a clinically-driven target revascularization (CD-TLR) rate of 7.1 percent.
"In our IN.PACT Global Study, IN.PACT Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions," said Mark Pacyna, vice president and general manager of the Peripheral business in Medtronic's Cardiac & Vascular Group. "Our new long lesion indication - coupled with the approval of the 200mm and 250mm balloons -furthers our commitment to the clinical community by equipping them with the tools and evidence needed to effectively treat complex cases."
About IN.PACT Admiral Drug-Coated Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with SFA disease. It was the first DCB to receive approval by the U.S. FDA for the treatment of in-stent restenosis and lesions up to 360mm in length. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, followed by the delivery of paclitaxel. With a unique dose and excipient, IN.PACT Admiral is intended to prevent artery narrowing by minimizing scar tissue formation.
IN.PACT Admiral received the CE (Conformité Européene) Mark in March 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. It has been studied in more than 20 individual clinical trials demonstrating durable safety and clinical benefits. To date, more than 200,000 patients have been treated with IN.PACT Admiral. It is the only DCB to have published three-year data and the first to have presented four-year data from a pivotal randomized trial.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Reported by Burt Cohen, June 23, 2018
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