Project kick-off meeting
On April 7, 2023, the clinical research kick-off meeting of ConFlow MedTech TriFlower's new foramen ovale obturator was successfully held in Zhongshan Hospital affiliated to Fudan University, marking that TriFlower's new foramen ovale obturator officially entered the phase of clinical trial subject enrollment. Academician Ge Junbo served as the main investigator in this clinical trial, and Professor Zhou Daxin's clinical team, Director Chen Haiyan of the Ultrasound Department, and Dr. Li Wei participated in the research.
Professor Zhou Daxin commenced the meeting with an informative speech, delving into the global and domestic breakthroughs in foramen ovale closure technology. He highly praised ConFlow MedTech's TriFlower foramen ovale obturator for its innovative features and reliability. Chen Xiumin, ConFlow MedTech's General Manager, introduced the development process and design attributes of the new TriFlower foramen ovale obturator. Clinical Project Manager Huang Ye presented the experiment's design, admission/discharge criteria, and testing procedures in detail. Professor Zhou Daxin subsequently authorized the specific tasks for the clinical project research.
During the meeting's discussion session, researchers engaged in a spirited discourse concerning the protocol, offering valuable recommendations to enhance the clinical trial's seamless advancement. They expressed strong confidence and optimism regarding the clinical trial of ConFlow MedTech's TriFlower, a novel foramen ovale obturator.
The launch meeting has successfully marked the initiation of the TriFlower Foramen Ovale Obturator project into an entirely brand-new phase. The forthcoming enrollment of the first clinical patient and the initiation of a multicenter randomized controlled trial are imminent. We anticipate that the clinical trials will comprehensively validate the safety and efficacy of the product, expediting its approval and subsequent launch, thereby providing enhanced benefits to patients suffering from patent foramen ovale.
TriFlower new foramen ovale obturator
The foramen ovale is a fissure in the middle of the atrial septum. Clinically, after the age of 3, the foramen ovale remains unclosed and is called patent foramen ovale (PFO). Some studies have shown that about 20% -25% of adults have incomplete foramen ovale closure. Studies have shown that patent foramen ovale is significantly related to a variety of cardio cerebral vascular disease.
ConFlow MedTech's independently developed TriFlower patent foramen ovale (PFO) closure device boasts a unique design that minimizes implant size and lowers thrombosis risk. This product features a dense polymer coating to expedite endothelialization, significantly enhancing the efficacy of oval hole closure. It offers various specifications to address complex PFO cases. Currently, the project has applied for four invention patents, four utility model patents (2 authorized), one PCT international patent, and one design patent.
The TriFlower foramen ovale obturator is applicable for patients between the ages of 18 and 65 who have received a cryptogenic stroke diagnosis and have documented moderate to large right-to-left shunting through the patent foramen ovale (PFO), as confirmed by imaging studies.
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September 17,2021Celebrating its one-year milestone, ConFlow MedTech successfully concluded its first-anniversary event, joined by supporters and partners.
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July 24,2023Good News | ConFlow MedTech was awarded as "Specialized and Sophisticated SME" in Shanghai City
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September 18,2023Thank you for being with us as we celebrate the third anniversary of ConFlow MedTech's establishment!
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