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Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany
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Prof. Dr. Dierk Scheinert
University Hospital of Leipzig |
January 21, 2016 -- Last weekend marked 52 years since the first angioplasty was done by Dr. Charles Dotter. But it wasn't performed in a coronary artery supplying the heart. It was done in a leg to prevent gangrene and amputation. Dotter was a radiologist and was experimenting with his iconoclastic concept of delivering therapy via catheter threaded inside the artery, as opposed to open surgery. He prophesied that "someday" his concept might be adapted to treat coronary artery disease.
A decade later, Andreas Gruentzig took on that challenge and developed PTCA, known today as PCI or coronary angioplasty, one of the most widely performed medical procedures worldwide.
But treatment of the peripheral arteries in the leg has not been as successful, especially in blockages below the knee (BTK) which too often become reblocked (known as restenosis). Many medical device manufacturers, Medtronic, Boston Scientific, Cook, C.R. Bard and more, have and are continuing attempts to solve this problem, from balloons to stents, to drug-coated balloons, with varying degrees of success. Some devices have worked better than others: the drug-coated balloon in particular has shown promise.
Today, a small company in Northern California, Mercator MedSystems, announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel.
Prof. Dr. Dierk Scheinert, Head of the Department of Interventional Angiology, University Hospital of Leipzig and the Principal Investigator for the trial, commented in a press release, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."
As with any device, what sounds intuitively correct must also be shown to improve outcomes. Peripheral interventional treatment has seen much promise in solutions that seemed revolutionary (lasers, radiation, etc.) only to see a minimal or even negative effect.
Hopefully, for patients suffering from peripheral artery disease (PAD), Mercator's device will increase the positive outcomes for this procedure.
This morning's press release from Mercator MedSystems, Inc. follows:
Mercator MedSystems Announces First Patient Enrolled in Below the Knee (BTK) Clinical Trial
January 21, 2016 -- Emeryville, California -- Mercator MedSystems, Inc., has announced their first patient enrollment from Bad Krozingen, Germany, in the company's LIMBO-PTA clinical trial. This trial combines localized drug delivery using the company's proprietary Bullfrog® Micro-Infusion Device of an off-the-shelf anti-inflammatory steroid (dexamethasone) with angioplasty. The study measures the benefit of adding drug delivery to the catheter-based re-opening of arteries below the knee in patients suffering from critical limb ischemia (CLI).
In vessels below the knee, while balloon angioplasty is able to open the clogged artery, a scarring process usually leads to re-obstruction of the vessel within 6 months of the procedure. The purpose of locally delivering an inexpensive generic anti-inflammatory drug to the vessel is to extinguish the biological signals that cause the buildup of scar tissue and lead to restenosis.
Two CLI trials are planned by Mercator, both of which are randomized, controlled trials: the German study (LIMBO-PTA), which pairs the therapy with angioplasty, and a United States study (LIMBO-ATX) which combines the therapy with atherectomy and has been submitted to the FDA. In angioplasty procedures, a high-pressure balloon is used to compress plaque and force the artery open, while atherectomy utilizes catheters with cutting blades or rough spinning surfaces to physically remove plaque from the artery. Both of these procedures are well known to cause blood vessel inflammation that leads to the re-occlusive scarring process.
The first patient in the LIMBO-PTA trial was treated by Dr. Elias Noory at the University Heart Center in Bad Krozingen, Germany. A total of up to 120 patients are intended to be enrolled over the coming months. Prof. Dr. Dierk Scheinert, Head Department of Interventional Angiology, University Hospital of Leipzig and the Principal Investigator of the trial, commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."
Trent Reutiman, the CEO of Mercator, noted, "This is a very important milestone for the company. There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results in above-knee arteries from our DANCE-Pilot study and our most recent experience from our larger, 285 patient DANCE trial provide us with confidence that our micro-infusion technology can place drug directly where it is needed and will have a strong benefit."
About Mercator
Mercator MedSystems, Inc., a privately-held Delaware corporation, is a medical device company focused on the clinical and commercial development of a proprietary, FDA-cleared and CE-marked catheter-based drug micro-infusion platform. The design enables the extreme targeting of drugs and/or biologics into tissue around blood vessels or airways to provide localized therapy.
Reported by Burt Cohen, January 21, 2016
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