The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires. Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and […]
SentreHeart
AtriCure closes $300m SentreHeart buyout
AtriCure (NSDQ:ATRC) said yesterday that it closed the $300 million buyout of SentreHeart and its Lariat left atrial appendage closure device. The offer included $40 million in up-front cash and stock, plus $140 million in clinical and regulatory milestones and $120 million in reimbursement milestones, all payable in cash and stock, Mason, Ohio-based AtriCure said when the […]
AtriCure offers $300m for SentreHeart
AtriCure (NSDQ:ATRC) said today that it put up a $300 million offer for SentreHeart and its Lariat left atrial appendage closure device. Redwood City, Calif.-based SentreHeart has enrolled 535 patients in the Amaze trial comparing Lariat and pulmonary vein isolation with PVI alone in treating atrial fibrillation. Today AtriCure said it expects the study tor each […]
SentreHeart touts first-in-human Lariat procedures with EpiRail
SentreHeart yesterday touted the first-in-human procedures involving its Lariat left atrial appendage closure device to reduce the risk of stroke in patients with atrial fibrillation. The initial nine procedures, performed by Drs. Kryzstof Bartus and Randy Lee at Krakow, Poland’s John Paul II hospital, used the EpiRail vacuum stabilization system for an epicardial-only, percutaneous approach […]
SentreHeart wins CE Mark, expanded indications for Lariat LAA devices
SentreHeart said today that it won CE Mark approval for its Lariat-RS 50mm and expanded labeling for the device for left atrial appendage exclusion. The Redwood City, Calif.-based company touted that its Lariat-RS device is different from other percutaneous LAA devices in Europe as it is the only non-implant solution for complete and permanent exclusion […]
SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA […]
SentreHeart logs German reimbursement win for Lariat, Eclipse LAA closure devices
SentreHeart said today that the German Institute for the Hospital Remuneration System granted renewed Status 1 to its Lariat and Eclipse left atrial appendage closure devices. The coverage will allow 50 hospitals under the NUB1 innovation program to negotiate for reimbursement to cover costs for treating patients with the Lariat for LAAC when such a procedure […]
SentreHeart recalls FindrWIRZ Guidewire System over coating separation issues
SentreHeart is recalling a select number of its FindWIRZ guidewire systems over PTFE coating separation issues, according to an FDA release posted today. The recall has been given a Class I label from the FDA, which indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. […]
SentreHeart closes $35m Series D for Lariat trial
SentreHeart said today that it landed a $35 million Series D round from Deerfield Management, with funds slated to support a trial evaluating its Lariat suture delivery system. The Amaze trial aims to investigate the use of Lariat for catheter-based left atrial appendage closure in patients with persistent atrial fibrillation, the Redwood City, Calif-based company […]
SentreHeart wins CE Mark for Lariat LAA closure device
SentreHeart said today it won CE Mark approval in the European Union for its Lariat surgical left atrial appendage suture delivery device used for soft tissue closure. The device is commonly used for the ligation of the LAA as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the Redwood City, Calif.-based company […]
Reva Medical snags ex-MDT’er Groves for CEO | Personnel Moves
Reva Medical (ASX:RVA) said last week it picked up ex-Medtronic (NYSE:MDT) divisional veep Regina Groves as its new CEO. Groves was vice president and GM of the atrial fibrillation solutions, cardiac rhythm and heart failure division at Medtronic. During her time there, she helped the company strategize a re-entry into the catheter-based atrial fibrillation ablation market, the […]