#None #Paris #Conformal Medical #CLAAS AcuFORM #LAAO Device

Conformal Medical Launches Pivotal Trial in Europe

Conformal Medical, Inc. has initiated patient enrollment for its innovative CONFORM Pivotal Trial in the European Union, testing the CLAAS® AcuFORM™ device—a groundbreaking technology for left atrial appendage occlusion (LAAO). This significant step comes as the first procedure in this trial was successfully conducted at the Institut Cardiovasculaire Paris Sud (ICPS) in France, under the skilled hands of Dr. Philippe Garot, who heads the interventional cardiology department.

The CLAAS AcuFORM device represents a new era in stroke prevention for patients suffering from non-valvular atrial fibrillation (AFib). Unlike traditional devices, this foam-based implant is designed for easier anatomical conformity, potentially changing how such procedures are performed. Dr. Garot emphasizes its importance, stating that this system could simplify procedures, enhance patient access to care, and ultimately lead to better health outcomes for AFib patients.

The CONFORM Pivotal Trial not only marks a considerable milestone for Conformal Medical but also highlights the expansive market opportunity for the CLAAS AcuFORM device throughout Europe. By leveraging Europe's varied healthcare systems and robust clinical networks, the trial aims to produce essential real-world data. This data is expected to facilitate increased physician adoption and lay a solid groundwork for future commercial ventures.

James Reinstein, the President and CEO of Conformal Medical, articulated the significance of this expansion into the European market. He remarked, "Our partnerships with leading European centers enhance our global presence, stimulate innovation, and position us favorably to provide our unique technology to patients around the world." He expressed confidence that the CLAAS AcuFORM will emerge as a competitive option given its capacity to adapt to varying anatomies, simplify the procedure process by using just two device sizes, and assure a reliable sealing process.

The CONFORM Pivotal Trial is a forward-thinking initiative comprised of a multicenter, randomized controlled study that aims to evaluate the safety and efficacy of the CLAAS AcuFORM system compared to existing LAA devices currently on the market. The study is expected to enroll around 1,600 patients globally. Progress is already underway, with over 30% of patient enrollment completed thus far.

The primary objective of this trial is to provide pivotal data that will support the emergence of next-generation therapies for stroke prevention in individuals with non-valvular AFib who desire alternatives to long-term anticoagulation therapies.

For more extensive details about the trial and enrollment information, prospective participants can visit Conformal Medical's dedicated CONFORM trial page.

This trial aligns with European Union regulations, specifically adhering to EU MDR Chapter VI, Article 62 4(i). Conformal Medical is on a mission to transform stroke prevention methods for AFib patients, showcasing their innovative approach towards making left atrial appendage closure a viable same-day procedure that can be performed by a single operator.

For further insights into Conformal Medical and their trailblazing technologies, please visit their official website at Conformal Medical. Note that this investigational device is strictly limited by federal law in the United States for investigational use only and is not approved for commercial application.

Conformal Medical’s proactive approach in enhancing stroke prevention technologies signifies a hope to significantly improve the lives of those affected by AFib through precise, streamlined treatments, paving the way for futuristic medical advancements in the field.