Cardiac
Abbott ablation device effective at 1 year in complex cases
Abbott's dual-energy ablation catheter, TactiFlex Duo, demonstrated safety and efficacy at one year in patients with atrial fibrillation, according to results from the FlexPulse IDE study presented at the European Society of Cardiology Congress and published in EP Europace. The device combines pulsed field and radiofrequency energy, offering flexibility in complex cases. The data underpin Abbott's FDA submission for U.S. marketing, following CE mark earlier this year.
Boston Scientific discontinues angiographic catheters
Boston Scientific has decided to halt sales and initiate a market recall of Imager II angiography catheters due to a manufacturing issue that poses a risk of the catheter tip detaching. The FDA has issued an early alert, and the company has reported two serious injury incidents.
Kardium receives $31M investment from Canada for manufacturing expansion
Kardium announced on Thursday that it will receive up to $31.25 million in funding from the Canadian government to invest in its medical device manufacturing facility. This funding will support the company's $125 million expansion project in Vancouver, British Columbia, where the Globe pulsed field ablation system is produced. Following prior FDA approval in the United States, Kardium is expanding capacity to drive the system's commercialization.
Abbott wins CE mark for new LAA closure device
On August 27, Abbott announced that its next-generation left atrial appendage (LAA) closure device, the Amulet 360, has received European CE marking. The device is used to close the left atrial appendage of the heart to reduce the risk of stroke in patients with atrial fibrillation (AFib). Abbott stated that the product's design optimizes fit and sealing performance against the left atrial appendage, and it plans to gradually roll it out in multiple European countries over the coming weeks. This move is seen as a key step by Abbott to challenge Boston Scientific's Watchman in the LAA closure market.
Medtronic veteran departs for CEO role at heart valve startup
Bill Shields, formerly Medtronic's VP and GM for transcatheter mitral and tricuspid therapies, has been named CEO of Versa Vascular. The Santa Cruz-based startup is advancing its AdapTR device for tricuspid regurgitation, backed by $42 million in Series C funding.
Philips forms 6 patient monitoring partnerships
Philips announced on Thursday partnerships with six companies aimed at expanding its open patient monitoring ecosystem, integrating wearable devices and out-of-hospital monitoring technologies to help healthcare systems continuously track patient status beyond the bedside. Partners include Blue Spark Technologies, Caretaker Medical, Cuviva, LifeSignals, Respiree, and smartQare. This follows a survey by the American Medical Association showing that physicians' use of wearable data is limited by workflow integration barriers.
Medtronic Affera System and Sphere-9 Catheter Receive CE Mark Expansion for Ventricular Tachycardia Ablation Treatment
Medtronic announced on Thursday that its Affera mapping and ablation system and Sphere-9 catheter received CE mark expanded indications for treating ventricular arrhythmias, including ventricular tachycardia. The FDA had previously granted breakthrough device designation to Sphere-9 to expedite its review in the United States. The Sphere VT pivotal trial is enrolling patients and will support a future US marketing application.
Siemens Healthineers and Cleveland Clinic Reach Ten-Year Strategic Partnership
Siemens Healthineers announced on Thursday a ten-year cooperation agreement with Cleveland Clinic to support its diagnostic imaging, cardiology, and radiation oncology services. Building on their 35-year existing relationship, the collaboration will provide technology and equipment including MRI, CT, radiation oncology, interventional radiology, and X-ray, along with an expanded dedicated service team.