Medtronic plc announced its intent to move forward with a new renal denervation pivotal trial following positive first results from a sham-controlled study in patients with high blood pressure. Investigators of the SPYRAL HTN-OFF MED Study found statistically significant and clinically important blood pressure reductions in the patients treated with renal denervation (RDN) across both office and ambulatory systolic and diastolic measurements. The data in the first 80 patients enrolled in the study at three months were presented in a late-breaking clinical trial session at the European Society of Cardiology (ESC) meeting, Aug. 26-30 in Barcelona, Spain and published simultaneously in The Lancet.

NaviGate Cardiac Structures Inc. (NCSI) announced that its Gate catheter-guided tricuspid atrioventricular valved stent (AVS) was implanted through the jugular vein six weeks ago into a patient’s transplanted heart that was failing due to severe tricuspid valve insufficiency. The successful implantation of the Gate AVS at the Policlinico of the University of Padua, Italy, represents the first European patient treated with the NCSI tricuspid replacement heart valve. Three hours after the intervention the patient was awake and showing improved renal function. Now, approximately two months post-procedure, the patient continues to demonstrate clinical improvement and excellent valvular function. This brings the total number of NCSI Gate tricuspid implants without 30-day mortality to three.

August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of ...