Sam Brusco, Associate Editor06.04.24
The U.S. Food and Drug Administration (FDA) Breakthrough Devices Program is a voluntary program for medical devices and device-led combination products that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It’s aim is to speed up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
Acceptance into the program allows a company to interact with FDA experts, receive feedback from the FDA, and identify areas of agreement in a timely manner. Manufacturers can also expect their submission to receive prioritized review.
Following are examples of some of the latest medical technologies accepted into the breakthrough device program.
The AltaValve transcatheter mitral valve replacement (TMVR) system was specifically designed to streamline transseptal delivery. Placed above the native mitral valve, its atrial-only fixation ensures that critical cardiac structures are retained in the left ventricle. It was engineered to minimize complications that sometimes arise during TMVR like device embolization, left ventricular outflow tract obstruction, and left ventricular dysfunction.
AltaValve’s stent allows for future left atrial access for other procedures. According to the company, it’s the only device designed to treat patients who have undergone previous valve repair.
4C Medical Technologies was awarded FDA breakthrough status in early May 2024. The status was granted for two indications: Treating moderate-to-severe mitral regurgitation (MR) and moderate-to-severe- or severe MR with moderate/severe mitral annular calcification (MAC).
The company has reported favorable results for patients treated in its early feasibility study. AltaValve was shown to be a promising option with high procedure success and MR elimination in most patients at 30 days, according to Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and an investigator in the study.
SetPoint’s integrated neurostimulation device is placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure. The device is then programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once daily to activate the inflammatory reflex for a systemic immune-restorative effect.
In early May 2024, the company was granted FDA breakthrough status to extend its neuroimmune modulation platform to relapsing-remitting multiple sclerosis (RRMS). There is currently no cure for MS, and while currently approved medicines can help slow down disease progression and, in some instances, ease some of the symptoms, there are no approved treatments that work by addressing the disorder’s root cause—myelin sheath damage.
In late April 2024, the company obtained FDA breakthrough status for MyKidneyAI, which analyzes retinal images from routine eye exams to detect elevated risk of chronic kidney disease (CKD) in patients with diabetes. Most patients with diabetes don’t receive routine screenings for CKD, which can cause the disease to be left undetected until it’s reached an advanced stage where straightforward interventions are no longer effective.
The retina is the only part of the vascular system that can be easily photographed to spot microvascular disease, which is a contributor to CKD. MyKidneyAI was built to help identify those with diabetes who have a higher CKD risk via a simple eye exam in eye care or primary care settings.
The company’s CLAiR technology also received initial breakthrough status in November 2023 for real-time cardiovascular disease risk assessments. CLAiR integrates readily with existing retinal imaging cameras with accuracy comparable to traditional cardiovascular risk assessment tools, according to the company.
Toku is working in close collaboration with strategic investors, as well as Topcon Healthcare (a provider of eye care medical devices and software solutions) and National Vision (a large U.S. optical retailer) to offer MyKidneyAI in the U.S.
Acceptance into the program allows a company to interact with FDA experts, receive feedback from the FDA, and identify areas of agreement in a timely manner. Manufacturers can also expect their submission to receive prioritized review.
Following are examples of some of the latest medical technologies accepted into the breakthrough device program.
AltaValve
Maple Grove, Minn.-based 4C Medical Technologies’ AltaValve aims to redefine solutions for mitral regurgitation. The company has created a new generation of minimally invasive technologies for structural heart disease.The AltaValve transcatheter mitral valve replacement (TMVR) system was specifically designed to streamline transseptal delivery. Placed above the native mitral valve, its atrial-only fixation ensures that critical cardiac structures are retained in the left ventricle. It was engineered to minimize complications that sometimes arise during TMVR like device embolization, left ventricular outflow tract obstruction, and left ventricular dysfunction.
AltaValve’s stent allows for future left atrial access for other procedures. According to the company, it’s the only device designed to treat patients who have undergone previous valve repair.
4C Medical Technologies was awarded FDA breakthrough status in early May 2024. The status was granted for two indications: Treating moderate-to-severe mitral regurgitation (MR) and moderate-to-severe- or severe MR with moderate/severe mitral annular calcification (MAC).
The company has reported favorable results for patients treated in its early feasibility study. AltaValve was shown to be a promising option with high procedure success and MR elimination in most patients at 30 days, according to Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and an investigator in the study.
Multiple Sclerosis
Valencia, Calif.-based SetPoint Medical’s mission is to develop chronic autoimmune disease treatments. Its platform technology offers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and other chronic autoimmune conditions with potentially less risk and cost than drug therapy.SetPoint’s integrated neurostimulation device is placed on the vagus nerve through a small incision on the left side of the neck in an outpatient procedure. The device is then programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once daily to activate the inflammatory reflex for a systemic immune-restorative effect.
In early May 2024, the company was granted FDA breakthrough status to extend its neuroimmune modulation platform to relapsing-remitting multiple sclerosis (RRMS). There is currently no cure for MS, and while currently approved medicines can help slow down disease progression and, in some instances, ease some of the symptoms, there are no approved treatments that work by addressing the disorder’s root cause—myelin sheath damage.
MyKidneyAI
San Diego, Calif-based Toku Inc. specializes in converting routine eye exams into comprehensive health screening by building artificial intelligence (AI)-powered tools.In late April 2024, the company obtained FDA breakthrough status for MyKidneyAI, which analyzes retinal images from routine eye exams to detect elevated risk of chronic kidney disease (CKD) in patients with diabetes. Most patients with diabetes don’t receive routine screenings for CKD, which can cause the disease to be left undetected until it’s reached an advanced stage where straightforward interventions are no longer effective.
The retina is the only part of the vascular system that can be easily photographed to spot microvascular disease, which is a contributor to CKD. MyKidneyAI was built to help identify those with diabetes who have a higher CKD risk via a simple eye exam in eye care or primary care settings.
The company’s CLAiR technology also received initial breakthrough status in November 2023 for real-time cardiovascular disease risk assessments. CLAiR integrates readily with existing retinal imaging cameras with accuracy comparable to traditional cardiovascular risk assessment tools, according to the company.
Toku is working in close collaboration with strategic investors, as well as Topcon Healthcare (a provider of eye care medical devices and software solutions) and National Vision (a large U.S. optical retailer) to offer MyKidneyAI in the U.S.