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FDA Expands Use for Transcarotid Stent
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Silk Road Medical Inc. shares traded 12% higher after the company reported that the U.S. FDA granted expanded authorization for its ENROUTEŽ transcarotid stent system for use in preventing stroke in patients deemed to be at standard risk for adverse events from carotid endarterectomy.

Medical device company Silk Road Medical Inc. (SILK:NASDAQ), which uses its collective knowledge of vascular diseases and surgical procedures to develop products that aid in reducing the risk and devastating impact of stroke, today announced that "the U.S. Food and Drug Administration (FDA) approved expanded indications for the ENROUTE stent to include patients at standard risk for adverse events from carotid endarterectomy (CEA)."

The company advised that the FDA had previously approved the use of its ENROUTE® transcarotid stent for use only in those patients classified as a higher risk for complications associated with more invasive surgical procedures.

Silk Road Medical's President and CEO Erica Rogers commented, "This is the first time in history that a stent-based approach has demonstrated non-inferiority in stroke and death rates relative to CEA, with our TCAR® system offering the added benefit of significantly reduced cranial nerve injury risk."

"This label expansion levels a playing field once dominated by open surgical techniques, allowing an expanded number of patients and physicians access to the benefits of a less invasive treatment option," Rogers added.

The company mentioned that it previously submitted extracted data from the Vascular Quality Initiative in a Premarket Approval (PMA) supplement to the FDA. The firm stated that the data was based upon real-world outcomes in over 20,000 patients who were considered to be at standard surgical risk. The company indicated that the data showed that "use of Silk Road Medical's TCAR® system is statistically non-inferior in stroke and death outcomes to CEA, while showing a ninefold reduction in cranial nerve injury (CNI) (2.7% vs 0.3%, p=<0.001)."

Dr. Marc L. Schermerhorn, Chief, Division of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center remarked, "Pairing the right patient with the right treatment results in significantly improved physician and patient experiences and outcomes. I speak for the vascular community in welcoming this label expansion for TCAR and recognizing this as a vital advancement in the treatment paradigm for patients at risk of stroke…The decision regarding which patients to treat with TCAR is no longer restricted to patients at high surgical risk, providing a greater opportunity for the care-team to pursue the less invasive approach for a broader set of their patients. At Beth Israel Deaconess, going forward, we expect that the right treatment for the majority of our atherosclerotic carotid disease patients will be TCAR."

The company explained that its ENROUTE transcarotid neuroprotection and stent system is designed for use in transcarotid artery revascularization procedures (TCAR). The firm noted that TCAR is a clinically proven, minimally invasive endovascular procedure that offers neuroprotection and treatment of blockages in the carotid artery which present an elevated risk of causing a stroke.

Silk Road Medical is a medical device company headquartered in Sunnyvale, Calif. that utilizes its expertise in vascular diseases and surgical procedures to develop devices that serve to reduce the risk and devastating impact of stroke. The company's ENROUTE Transcarotid Stent was developed for use in both standard and high-risk patients for complications from CEA. The Stent is intended for use in conjunction with Silk Road's ENROUTE Transcarotid Neuroprotection System (NPS) during the endovascular procedure. The firm listed that ENROUTE Transcarotid NPS is employed to "directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent."

Silk Road Medical started the day with a market cap of around $1.2 billion with approximately 35.0 million shares outstanding and a short interest of about 6.2%. SILK shares opened more than 2% higher today at $35.85 (+$0.80, +2.25%) over Friday's $35.05 closing price. The stock traded today between $35.71 and $40.7476 per share and closed at $39.98 (+$4.93, +14.07%).

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