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FDA News
Amplatzer Talisman PFO Occluder and Delivery Sheath Get Nods from FDA
September 30, 2021
Abbott announced on September 29 the FDA had granted approval to the Amplatzer Talisman PFO Occluder for use in patients with a PFO at risk of recurrent stroke. This approval was accompanied by the clearance of the Amplatzer Talisman Delivery Sheath.
Evolocumab Approved for Pediatric Patients with Heterozygous Familial Hypercholesterolemia
September 27, 2021
Announced on September 24, the approval is for use as an adjunct to diet and other LDL-C-lowering therapies for reducing LDL-C in patients aged 10 years and older with heterozygous familial hypercholesterolemia.
Cardiology Month in Review: September 2021
September 25, 2021
September's cardiology month in review features FDA news related to empagliflozin and tofacitinib, a study into the potential impact of sacubitril/valsartan's label expansion, and a study from HFSA 2021.
FDA Approves Portico with FlexNav TAVR System from Abbott
September 20, 2021
On September 20, Abbott announced the FDA had approved their Portico with FlexNav TAVR system for patients with symptomatic, severe aortic stenosis based on results of the PORTICO IDE Trial.
FDA Issues Warning Over Potential Cardiovascular Disease Risk with Tofacitinib
September 10, 2021
Announced in a statement on September 1, the FDA warning is an update to the FDA Drug Safety Communication issued on February 4, 2021 and the results of a review of a trial that found a serious increased risk of CV-related events with the drug.
FDA Grants Empagliflozin Breakthrough Therapy Designation for HFpEF
September 09, 2021
Announced by Boehringer Ingelheim and Eli Lilly and Company on September 9, the Breakthrough Therapy designation for empagliflozin is based on the results of the EMPEROR-Preserved trial.
FDA Approves OCS Heart System for Hearts from DBD Donors
September 07, 2021
Announced in a statement from TransMedics Group Inc. on September 7, premarket approval to the OCS Heart System could allow for broader utilization of donor hearts for transplantation in the US.
FDA Approves Rivaroxaban for Use After Lower Extremity Revascularization in Peripheral Artery Disease
August 24, 2021
Announced on August 24, rivaroxaban (Xarelto) has received its ninth indication from the US FDA. This time, the FDA has approved a label expansion to include patients with symptomatic peripheral artery disease who have undergone lower extremity revascularization.
Medtronic's Evolut FX TAVR System Receives Approval for Severe Aortic Stenosis
August 24, 2021
With approval of the Evolut FX TAVR System announced on August 24, the Evolut TAVR Platform is now indicated for symptomatic severe aortic stenosis across all patient risk categories.
Empagliflozin (Jardiance) Receives FDA Approval for Heart Failure with Reduced Ejection Fraction
August 18, 2021
The approval of empagliflozin for reducing risk of CV death and hospitalization for heart failure in patients with HFrEF comes less than a year after results of EMPEROR-Reduced were presented at ESC 2020.