This lesion-level pooled data analysis of 588 patients and 700 lesions represents the “largest and most diverse cohort of any single angiogram-based FFR technology reported.” Results indicate FFRangio has excellent diagnostic performance, strong correlation, and that results were robust across a wide spectrum of patients and lesion characteristics.
PCI in patients with FFR ≤ 0.80 reduced clinical events by 66% compared to medical therapy alone at 1 year.
The FAME II Trial randomized stable CAD patients with FFR ≤ 0.80 to PCI + medical therapy or medical therapy alone. Enrollment was halted early after 1,220 patients because of a significant between-group difference in the events, driven by a lower rate of urgent revascularization in the PCI group than in the medical therapy group. Continue reading “FAME II Trial”
Economic analysis of the FAME Trial revealed that PCI guided by FFR saves costs and improves health outcomes at 1 year compared with angiography guidance. Cost savings are driven by a decrease in stent use during the initial procedure, a decrease in rehospitalization and fewer major adverse cardiac events. Continue reading “FAME Trial Economic Analysis”
92% Diagnostic Accuracy, 94% Sensitivity, and 91% Specificity
The FAST-FFR pivotal trial was a prospective multicenter, international trial designed to determine the accuracy of FFRangio in clinical practice compared to traditional wire-based FFR. The trial included 301 patients and 319 vessels at 10 clinical sites. The results demonstrated excellent diagnostic performance, including in the grey zone between FFR values of 0.75 and 0.85. Continue reading “FAST-FFR Pivotal Trial”
High concordance with invasive FFR wires, 93% diagnostic accuracy
The FFRangio Validation study evaluated 203 lesions in 184 patients and showed that there is high concordance between FFRangio and invasive FFR, including a diagnostic accuracy of 93%. Continue reading “FFRangio Validation Study”
KFAR-SABA, ISRAEL & ALISO VIEJO, CA (December 10, 2019) — CathWorks today announced the approval of The CathWorks FFRangio™ System by the Japan’s Ministry of Health, Labour and Welfare (MHLW).
The CathWorks FFRangio System is a non-invasive diagnostic technology that is used at the time of a routine angiography. The CathWorks FFRangio System transforms routine angiogram images into objective and comprehensive physiology information, including color-coded 3D renderings of blood flow in the heart’s arteries to help physicians optimize coronary artery disease decision making, including whether a stent is needed.
The CathWorks FFRangio System is also commercially available in the United States and Europe. It is noninvasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. The technology has the potential to positively impact a significant patient population in Japan, where heart disease is the second leading cause of death and coronary artery disease accounts for approximately half of these deaths.1
“The MHLW’s approval of The CathWorks FFRangio System is another important milestone for CathWorks, physicians and patients. It is the first non-invasive device of its kind to receive Japan MHLW approval for use during Percutaneous Coronary Intervention (PCI) and to determine the optimal treatment for patients with coronary artery disease” said Jim Corbett, CEO of CathWorks. “With this approval in Japan, we are positioned to significantly expand our ability to help more clinicians optimize coronary artery disease therapy decisions non-invasively while reducing unnecessary invasive catheterizations and saving costs.”
KFAR-SABA, ISRAEL and ALISO VIEJO, CA (March 4, 2019) — CathWorks announced that Mike Feher has joined CathWorks as Vice President of Finance and Chief Financial Officer. His appointment coincides with US commercialization of the CathWorks FFRangio™ System. Mr. Feher will initially focus on the development of financial and operational capabilities, as well as creating value for the organization through the execution of company’s strategy.
Mike joins CathWorks with over 13 years of finance and strategy experience in companies such as Edwards Lifesciences, Volcom and Deloitte. That experience includes deep understanding of investor relationships, strategic planning and financial operations. Mike is a certified public accountant. He earned his B.S. in Accounting, Finance and Economics from Chapman University and his MBA from University of Southern California.
Jim Corbett, CathWorks CEO, said of Mike’s appointment, “I am very excited to have Mike join our leadership team. Mike’s strategic mindset and broad financial acumen will be a significant addition to our team. The CathWorks System represents a tremendous opportunity for interventional cardiologists to improve the quality of care and lower costs in the treatment of multi-vessel coronary artery disease. I am confident in Mike’s ability to lead our finance organization as we continue to work towards achieving our strategic plan.”
Mr. Feher said, “I am excited about joining CathWorks and its dynamic leadership team. We look forward to the US commercialization of the CathWorks FFRangio in the next few weeks and cannot wait to see the impact of this transformational technology on patients, physicians, and health systems.”
The CathWorks FFRangio System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions for every patient. It is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per-procedure costs. The company received U.S. FDA 510(k) clearance for the CathWorks FFRangio Coronary Vascular Physiologic Simulation Software on December 19, 2018.
Learn how the CathWorks FFRangio™ System can impact your practice.