www.IdeasForSurgery.com Further… April 3, 2007 Out of the fox hole?

In a press release, FoxHollow Technologies announced today that it has introduced the SilverHawk(R) SXL as an Enhanced Plaque Removal Technology for Treating Peripheral Artery Disease (PAD). Is the market acceptance of such a product hindered by available alternatives such as angioplasty, stenting or bypass grafting? Or are the well-known stent and angioplasty device manufacturers, such as Abbott Laboratories, Boston Scientific, Cook, Johnson & Johnson and Medtronic sweating because of the COURAGE study news? Now more then ever the SilverHawk(R) technology could use some compelling data from long-term studies about the safety and efficacy. The company recently initiated the enrollment for a study called PROOF, comparing treatment with the SilverHawk to bypass grafting. Don’t expect any initial data for a year or so and expect the final results not sooner then several years from now. So far a limited number of clinical experiences with small patient populations have generated one year follow data for short and mid-term restenosis and patency rates. The rate of restenosis, or plaque regrowth following the SilverHawk procedure, and the corresponding duration of openness of the artery will speak volumes. Typically two-year restenosis rates are substantially higher than one-year results and physicians tell us that they will look for the rate of reintervention, or retreatment, and compare it against alternative procedures, such as bypass grafting. The SilverHawk(R) technology is relatively new in the treatment of PAD. It was commercially launched in the USA at the beginning of 2004. It is a minimally-invasive plaque excision system, based on catheter that removes plaque and reopens narrowed or blocked arteries. Both, the battery-driven control unit and the catheter are disposable. The SilverHawk sales people see interventional cardiologists and vascular surgeons because they are often the primary care physicians diagnosing and treating PAD. However, for many PAD patients the initial point of contact may be general practitioners, podiatrists, nephrologists or endocrinologists which are seen for treatment of the complications resulting from PAD. It is a huge task to educate these referring physicians

about PAD in general and the existence of the SilverHawk technology in particular. Nevertheless, if a primary care giver does not refer patients to interventional cardiologists, vascular surgeons or interventional radiologists for the SilverHawk procedures, the patient ends up being treated surgically or with an alternative interventional procedure. It does not help that the market approval for the SilverHawk in the United States is limited to use in peripheral vessels. There is a significant correlation between PAD and coronary artery disease. Most physicians choose not to screen routinely for PAD while screening for coronary artery disease. The limited FDA approval has not stopped off-label use of the SilverHawk outside the peripheral vasculature, in coronary and carotid arteries. FoxHollow started a clinical trial in support of FDA approval for use of the SilverHawk in the coronary arteries but voluntarily halted enrollment because of serious adverse events, including perforations. In the meantime safety and design improvements such as on-board visualization capability are being addressed. The coronary application presents a major challenge because of the patients’ overall poor health, the complexity of treating the bifurcated lesions and the size of coronary arteries, as well as the fact that they are constantly moving as the heart beats. And there is competition building for the PAD market segment: the Cook Group is conducting clinical trials for the use of drug-eluting stents and Edwards Lifesciences is conducting clinical trials for the use of non-drugeluting stents in the peripheral vasculature. We will watch carefully other companies developing plaque-removal devices intended for the treatment of PAD, such as Cardiovascular Systems, Inc. and Pathway Medical. The future success of SilverHawk depends on several factors. I mentioned the necessary design improvements to enhance safe use of the device. Under no circumstance should there be excised arterial plaque entering the bloodstream. If the device does not capture the plaque properly, it could be carried by the bloodstream and blocking an artery. Physicians have expressed their need to cut the time required to perform the procedure. By now, everybody at FoxHollow is aware of the need for consistent high quality manufacturing in order to avoid voluntary recalls such as the one in June 2004. Two lots of the SilverHawk had to be taken off the market due to the possibility of improper sterilization. I am excited to see FoxHollow expand their marketing claims and file for additional FDA clearances or approvals. This will generate new customers

(and retain existing customers for that matter) and may influence the rate of SilverHawk adoption. K.T.