A Medical Device Daily
Since last year drug eluting stent (DES) technology has come under significant fire — producing negative trial data and headlines, receiving tough scrutiny from the FDA, getting pushed back by the market.
But does a company then shy away from this "novel" and "disruptive" technology.
Not Global Therapeutics, (Broomfield, Colorado), a business of Cook Medical (Bloomington, Indiana). Rather, it is looking at DES, together with bare metal stents (BMS), in a different light and going for the best of both med-tech worlds.
The result: a device that marries features of the two types of stents in order to "silence" the controversial aspects of DES.
The new stent system, which hasn't been named yet, employs a follow-on an antisense agent (AVI-5126), developed by AVI Bio Pharma (Portland, Oregon), to arrest the process of restenosis after treatment with angioplasty/stenting.
Cook last year licensed from AVI the antisense technology, brand-named Neugene, for down-regulating c-myc gene expression in the field of cardiovascular disease (Medical Device Daily, March 13, 2006).
Currently the device/procedure combination has been tested in preclinical trials and has shown favorable results, according to the company.
"We wanted to have a very simple system," Joe Horn, president of Global Therapeutics told MDD. "It's a combination product. It's a hybrid."
Explaining how it works, he said: "A cardiologist would put in a bare stent where the restenosis was occurring, [and] they would leave a guidewire — take out the stent balloon and put in a catheter just proximal to the stent in the artery. They would then take a syringe loaded with antisense and would slowly inject it into the catheter. That's the process — that's all it is. This removes the fear of restenosis."
The anti-sense agent serves to silence the c-myc gene, thought to be one of the main causes of restenosis.
"We view this kit as a unique system needed by the industry given all the negative press surrounding the current generation of pharmaceutical-eluting coronary stents," Horn said. "Antisense therapy to prevent in-stent stenosis is an exciting breakthrough in the treatment of coronary artery disease. Sub-selective delivery of AVI-5126 will open a new approach combining the safety of a bare metal stent with reducing restenosis comparable to DES."
Horn said that plans call for a clinical trial in Europe later this year, possibly by November.
This isn't the company's first foray into attempting to provide advanced evolution of DES.
In July the company unveiled the results of its APPRAISAL trial, which indicated that a drug delivered to a patient following stent placement may be just as effective, or more so, than a drug attached to and eluting from a stent device, thus perhaps bypassing the need for the device/drug combo (MDD, July 10, 2007).
Phase II of those trials was held in Germany and France and enrolled about 52 patients in a six-month-study. The patients suffered from symptomatic ischemic heart disease and the stenotic lesion of native coronary arteries. About 80 % of the patients in the study were type B2, C-lesions – some of the more serious cases in cardiovascular illnesses.
In the study, clinicians administered Resten-MP within 60 minutes of successful stent placement in the coronary artery, and again 24 hours later, via slow-push intravenous administration.
Meanwhile, med-tech companies still navigating the troubled DES waters were thrown somewhat of a life preserver last week in the form of study in the August edition of the Journal of the American College of Cardiology, though this too, involves the use of a follow-on procedure.
Authored by Dr. George Sianos and colleagues at the Thorax Center (Rotterdam, the Netherlands), the study shows that when AngioJet Thrombectomy, a device made by Possis Medical (Minneapolis). is used to remove large thrombus before placement of a DES device, it is associated with significantly lower rates of subsequent death, repeat heart attack and stent thrombosis (MDD, August 10, 2007).
These and other developments appear to indicate that the iterations of DES technology will continue — with significant alterations and, perhaps, a dizzying array of choices to be made by clinicians.