Cook Medical has received premarket approval from the US Food and Drug Administration for its lower-profile Zenith Alpha Thoracic endovascular graft. Zenith Alpha Thoracic is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) that have vascular anatomy suitable for endovascular repair. The approval of Zenith Alpha Thoracic was based on two clinical trials that studied the safety and effectiveness of the device in patients with aortic aneurysm/ulcer or blunt traumatic aortic injury.
Zenith Alpha Thoracic will allow physicians to treat more patients endovascularly due to its lower-profile introduction system and broad range of sizes. With a 16- to 20-F delivery system, Zenith Alpha Thoracic was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy.
The device’s introduction system also features an ergonomic design that requires fewer procedural steps than previous designs to deploy the device without sacrificing the precision and control of the Zenith platform.
The NeuWave Medical Intelligent Ablation System is the first intelligent ablation system. The totality of the system allows physicians to tailor their approach to each patient’s clinical needs and offers the first and only integrated in-procedure confirmation of ablation.
Ablation Confirmation (AC) is a CT image processing software that resides on a second, dedicated monitor on the NeuWave Medical Intelligent Ablation System. AC reduces uncertainty in procedures by assisting physicians in proper ablation probe placement and confirming ablation zones postprocedure. AC imports images from CT scanners and facility PACS and uses a deformable registration to overlay probe placement and ablation zone scans with the identified target. Two-dimensional and three-dimensional visualizations are provided to assess proper probe placement and confirm technical success of the procedure. Additional features of AC include remote viewing from an external computer and the ability to save AC images back to PACS, which supports case reporting, referral follow-up, data publication, and the establishment of treatment protocols. The NeuWave Intelligent Ablation System is available for sale in the United States and outside the United States. Ablation Confirmation is cleared for sale in the United States, but not yet available for sale outside the United States.
Surefire Medical has received clearance in the United States and Europe for the Surefire Precision infusion system. The Surefire Precision expands the company’s line of infusion systems that control arterial pressure to significantly increase drug delivery into tumors—by as much as 90%, according to published clinical data—while reducing nontarget delivery to healthy tissue. The Surefire Precision is designed for minimally invasive embolization procedures to treat hepatocelluar carcinoma and potentially other conditions. Embolization is the standard of care in the treatment of primary liver tumors, 80% of which are nonresectable. Primary liver tumors often contain regions of high pressure and no blood flow, which creates a barrier to drug delivery, resulting in poor tumor response. The embolization industry has historically focused on the size of the embolic agent to increase tumor penetration; however, the delivery system also matters. The Surefire Precision system reacts to local flow conditions feeding the tumor, automatically increasing pressure during infusion and resulting in increased deposition of the drug in regions of the tumor that would otherwise potentially remain untreated.