This is a big month for news in the vascular field. With two of the largest vascular meetings, ISET and LINC, occurring in the same week, news keeps flooding in about results presented at meetings and new devices announcing CE mark or FDA approval. Just today, several news stories came across the wire. For example, Cardiovascular Systems, Inc., announced that results from their CONFIRM trial show that CSI’s minimally invasive orbital atherectomy system is an effective treatment for peripheral arterial disease.
“Orbital atherectomy led to low bail-out-stent usage, low adverse procedural-event rates and improved lesion compliance. Additionally, smaller randomized studies point to improved vessel durability and long-term outcomes—both of which are a first for atherectomy trials in the peripheral vascular space,” said Dr. Tony Das, Cardiology and Interventional Associates, Dallas, Texas, who presented the results at ISET.
Another news story from Medtronic announced that its Complete SE self-expanding stent, under review by the FDA for use in lower-extremity arteries, has now received CE mark for that use. The stent is approved by the FDA for use in the iliac arteries. The approval came after results of the Complete SE SFA study that enrolled 196 patients at 28 sites in the United States and Europe showed a low clinically-driven target lesion revascularization rate of 8.4% at 12 months.
Spectranetics also announced results from the PATENT study (Photo-Ablation using the TURBO-Booster and Excimer Laser for In-Stent Restenosis Treatment), which evaluated the safety and efficacy of its peripheral laser atherectomy catheters for the treatment of in-stent restenosis (ISR) in the femoropopliteal artery. There is currently no FDA-approved device to treat peripheral in-stent restenosis, so results of this study could be important to the future treatment of patients with this condition in the United States. The freedom from target lesion revascularization rate within the PATENT study exceeds the targeted rate in the randomized, controlled EXCITE ISR trial, bringing even more confidence about the success of the technique.
Endologix announced CE mark awarded to the Nellix EndoVascular Aneurysm Sealing System, a device for treatment of abdominal aortic aneurysm. Nellix is the first available endovascular aneurysm sealing (“EVAS”) system. EVAS with Nellix is designed to simplify endovascular AAA procedures, treat a broad range of patients, and provide enhanced clinical outcomes. The system is not yet under review by the FDA.
In device manufacturer news, AngioDynamics anounced that it will acquire certain assets of Microsulis Medical Ltd., including leading microwave ablation technology and its worldwide distribution rights. Among the devices is the Accu2i pMTA microwave ablation system for percutaneous use, which utilizes a single, high-power, high-frequency 2.45 GHz saline-cooled needle that delivers significant advantages to clinicians and patients, including faster and larger soft tissue ablations.
Will these devices affect your ability to bring good results to your patients? Share your thoughts in the comments below.