Cook Medical said Monday it launched the Advance salivary duct balloon catheter designed to dilate structures in the submandibular and parotid salivary ducts.
The device is the Bloomington, Ind.-based company’s 1st high-pressure balloon specifically for salivary duct intervention.
“Stenosis of the salivary ducts can significantly impact a person’s quality of life. There is a clear unmet clinical need for more effective minimally invasive treatment options for salivary duct strictures. We are proud to provide clinicians with the Advance salivary duct balloon catheter set to help treat patients in the area of sialendoscopy,” Cook OHNS division global leader Thomas Cherry said in prepared remarks.
The device set contains a hydrophilic-coated balloon catheter and a wired guide, and controlled inflation of the device allows dilation of strictures in affected salivary ducts.
Earlier this month, Cook said it won premarket approval from the FDA for its Zenith Alpha thoracic endovascular stent graft designed for patients with isolated lesions of the descending thoracic aorta.
The approval came based on 2 pivotal clinical trials examining the safety and effectiveness of the graft in patients with aortic aneurysms or ulcers or with blunt traumatic aortic injuries, Cook said.
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