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Endovascular Introduces Newest Innovations: Silverhawk™ and Outback®
Time breeds change, and with it advancements never before imagined. The field of vascular medicine is without exception. Where once vascular bypass surgery existed as the only viable option for artery repair, soon came other alternatives: angioplasty, improved upon with stenting, outdone by Cryoplasty. Today, the SilverHawk™ Plaque Excision System and Outback® Re-Entry Catheter dominate headlines, and Deborah Heart and Lung Center’s Department of Endovascular Medicine, with its implementation of both, has reasserted itself a leader in patient care.
“Deborah has long prided itself on being at the forefront of technology, offering to our patients the most advanced and efficacious procedures available,” stated Manu Rajachandran, MD, Chairman, Department of Endovascular Medicine at Deborah. “The Silverhawk Plaque Excision System and Outback Re-Entry Catheter are two such examples of that commitment.”
Both FDA-approved devices, the SilverHawk Plaque Excision System and Outback Re-Entry Catheter each have niche applications. The former is used for the treatment of de novo and restenotic lesions in the peripheral arteries by removing significant amounts of atherosclerotic tissue from long, diffusely diseased lesions while avoiding significant barotrauma. The latter is used to facilitate placement and positioning of guidewires/ catheters within the peripheral vasculature, across resistant and very severe arterial blockages.
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Each requires a minimally invasive procedure in which the device is deployed into the diseased artery through a small incision in the groin. The Silverhawk Plaque Excision System uses a tiny rotating blade to shave away plaque from inside the artery. As it is excised, the plaque collects in the nosecone of the device, which, when full, can be removed, cleaned and re-inserted to treat additional areas within the same lesion or additional lesions. The Outback Re-Entry Catheter uses a guidewire that allows physicians to successfully cross lesions that are 100 percent blocked, creating a channel across the occlusion. These occlusions were previously only treatable with the more invasive bypass surgery.
“Since implementing the Silverhawk Plaque Excision System and Outback Re-Entry Catheter over 18 months ago, we, at Deborah, have experienced nothing but success,” said Dr. Rajachandran, citing the more than three dozen patients who have received the therapies. “They are both excellent devices whose applications range from debulking lesions at bends and branch points in the arteries, as well as treating the renarrowing or scar tissue formation often found in stents, to crossing ‘uncrossable’ blockages.”
This should come as welcome news to the approximately 12 million Americans living with Peripheral Arterial Disease (PAD), a population that could most benefit from the Silverhawk’s angiographic results or the Outback Re-Entry Catheter’s maneuverability.
PAD is a crippling condition that results from an accumulation of plaque in the arteries of the pelvis and legs. If left untreated, PAD can increase the risk of heart attack and stroke, and can ultimately lead to amputation or death. In fact, whether symptomatic or not, patients with PAD face a five-year mortality rate of 30 percent. Symptoms of the disease can include, but are not limited to: claudication or leg pain with ambulation; numbness or tingling in the leg, foot or toes; changes in skin temperature; changes in skin color; impotence; sores or infections that do not heal; and weakness in the legs or arms. Those most prone to developing PAD are smokers, men and women over 70, diabetics and patients with coronary artery disease. “For many Americans suffering with PAD, those handicapped by the pain of walking or facing limb amputation, the Silverhawk Plaque Excision System can provide a new outlook on life,” explained Dr. Rajachandran. “Likewise, for patients with blockages in the superficial femoral artery or the popliteal artery that have been unsuccessfully treated in the past, the Outback Re-Entry Catheter is proving to be an excellent minimally invasive alternative to surgery.”
Last year alone, over 150,000 amputations were performed in the US for critical PAD of the legs. As for using the two devices collaboratively, Dr. Rajachandran admits the possibility, but points out that the Outback Catheter is used primarily in “hard to treat” disease; the Silverhawk Plaque Excision System achieves its luminal gain through plaque removal, and minimizes the need for stents. If, however, restenosis should occur within the stent, the Silverhawk System could be used to address the renarrowing, which is yet another “niche” application of this unique new device.
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