Gunnar Tepe, MD, Head of Diagnostic and Interventional Radiology at the Academic Hospital of Rosenheim, Rosenheim, Germany, described his experience with the Proteus device at the 2010 VEITHsymposium in New York.
What are the indications for the Proteus balloon catheter device?
The Proteus device (Angioslide, Inc., Minneapolis, Minnesota) is approved for prevention of embolization during intervention in peripheral arteries and might especially be used where thrombus is present or after atherectomy. Other possible indications for the Proteus are in renal arteries to maintain renal function and for use in carotid arteries. The Proteus is an angioplasty balloon with a 97–99% technical success rate and a vessel dissection rate of
How many patients have undergone treatment with this device to date?
Thus far, 123 patients have undergone treatment in controlled studies, although thousands more of these devices have been used to date.
What has your experience been thus far with the recently approved Proteus device?
I have found the Proteus very easy to use, in that it operates like a traditional PTA balloon catheter, but with a larger sheath size.
Describe this device and how Proteus is deployed.
Proteus is deployed like a normal PTA balloon, but deflation time is longer and is done from the distal to proximal portion of the lesion in order to capture the embolic material. When first deployed, Proteus functions as a normal angioplasty balloon and is inflated to 8 atm. The balloon is then deflated to 2 atm, with continued occlusion of blood flow, at which point the balloon captures any resulting embolic debris as it rolls in upon itself.
What is the learning curve for the Proteus device compared to the traditional embolic filter systems?
Proteus is very easy to use and requires little additional time; intervention equals protection.
What do you anticipate the long-term outcomes will be with the Proteus device?
I do not anticipate any changes from the current standard, which reflects the results of plain balloon angioplasty. The long-term patency results do not differ from those with PTA.
Will the Proteus device offer cost savings to centers that use it?
This needs to be investigated in clinical studies, but some of the likely cost savings include the prevention of embolization and elimination of the need for a thrombus aspiration device. And in some areas such as the renal arteries and the carotid artery, complications from embolization, if they have already occurred, may not be able to be resolved by endovascular means.
How does the Proteus device compare with the currently used embolic filter systems?
In animals, the Proteus device has performed better (i.e., the in-rolling mechanism of the balloon caused no increase in vessel injury in porcine models), but no comparison has yet been made in clinical settings.[>
Are there clinical scenarios in which the traditional filter systems would still be best to use?
With atherectomy procedures, a filter must be used (like with the TurboHawk device).
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VASCULAR DISEASE MANAGEMENT 2011;8:E9–E10