The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time.
Both oxidative stress and inflammation are the main hallmarks in the development of heart failure. Researchers from the Hefei University of Technology have reported on the discovery and optimization of a series of pterostilbene derivatives intended to be used in heart failure.
Merck & Co. Inc. is pledging major resources on its prospect in the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor space with a phase III program that together will enroll about 17,000 subjects and test oral peptide MK-0616’s effect on tackling low-density lipoprotein cholesterol.
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
Eli Lilly & Co. has described pyrrolidine compounds targeting apolipoprotein(a) (Apo[a]) and acting as lipoprotein(a)-lowering agents reported to be useful for the treatment of cardiovascular disorders.
Obesity is known to be associated with metabolic and cardiovascular disorders such as insulin resistance, type 2 diabetes, hypertension, or heart failure, all presenting a chronic low-grade inflammatory component. The activation of the NLRP3 inflammasome pathway appears to be linked to the development of cardio-metabolic diseases.
The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
Protease form factor Xia (FXIa) is a therapeutic target for thrombosis prevention due to its well-known contribution to VTE and ischemic stroke in humans. Researchers from Janssen Pharmaceutica NV presented an antithrombotic target FXIa inhibitor obtained through a non-classical interactions strategy to improve the pharmacokinetic and pharmacological activity for the treatment of thrombosis. In the series, the potency was increased by using water-mediated hydrogen bonds to reduce polar hydrogen bond donors and using methyl to displace high-energy waters.
The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work in these two device categories have faced seemingly routine recalls over the past couple of years. The U.S. FDA recently reported yet another round of class I recalls for a single model in both Abiomed Inc.’s Impella line of VADs and Datascope Corp.’s Cardiosave line of IABPs, but the agency’s apparent unwillingness to force either manufacturer to withdraw any of these recalled products seems to suggest that product shortages would quickly follow any such move on the FDA’s part.
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