Penumbra (NYSE:PEN) announced today that it launched the Lightning Flash 3.0 computer-assisted vacuum thrombectomy (CAVT) system. The latest-generation Lightning Flash CAVT offering includes significant upgrades, advancing Penumbra's venous thromboembolism (VTE) platform, the company says. Penumbra — which is set to be acquired by Boston … [Read more...] about Penumbra launches next-gen Lightning Flash 3.0 thrombectomy system
Technologies & Devices
Medtronic wins CE mark for Affera Sphere-360 PFA catheter, reports first U.S. IDE cases
Medtronic (NYSE: MDT) announced two new milestones for its Affera Sphere-360 catheter for pulsed field ablation (PFA) procedures. First, the medtech giant received CE mark approval for the first-of-its-kind, all-in-one mapping and single-shot PFA catheter. It also completed the first cases for the paroxysmal AFib treatment system in the Horizon … [Read more...] about Medtronic wins CE mark for Affera Sphere-360 PFA catheter, reports first U.S. IDE cases
Medtronic to invest up to $90M in Anteris Technologies
Anteris Technologies (Nasdaq: AVR, ASX: AVR) says medtech giant Medtronic (NYSE: MDT) will make a strategic investment of up to $90 million in the transcatheter heart valve developer. The private placement, announced after market close yesterday, requires Medtronic to acquire a 16.0–19.99% stake in Anteris. In addition, Anteris is proposing a … [Read more...] about Medtronic to invest up to $90M in Anteris Technologies
Abbott picks up CE mark for TactiFlex dual-energy ablation catheter
Abbott (NYSE:ABT) Abbott (NYSE: ABT)+ announced today that it received CE mark for its TactiFlex Duo Ablation Catheter, Sensor-Enabled, to treat AFib. Following approval, the company also reported the first commercial cases using the catheter in Europe, completed this week. Dr. Isabel Deisenhofer, head of the department of Electrophysiology at … [Read more...] about Abbott picks up CE mark for TactiFlex dual-energy ablation catheter
Vantive updates instructions after dialysis system tubing issue
The FDA issued a notice related to updated instructions for the Vantive Prismaflex control units after reports of a potential tubing issue. Vantive, the former kidney care unit of Baxter, issued a letter on Jan. 6 informing customers of the updated instructions. The FDA said it became aware of the "potentially high-risk device issue" related to … [Read more...] about Vantive updates instructions after dialysis system tubing issue
Boston Scientific to acquire Penumbra for $14.5B
Boston Scientific (NYSE: BSX) today announced a definitive agreement to acquire cardiovascular disease treatment device maker Penumbra (NYSE:PEN). The deal values Penumbra at $374 per share, reflecting an enterprise value of approximately $14.5 billion. Penumbra shares currently trade at approximately $313.43 apiece ahead of the market opening … [Read more...] about Boston Scientific to acquire Penumbra for $14.5B
Boston Scientific reports first peripheral cases in Seismiq IVL rollout
A Boston Scientific (NYSE: BSX) today took to social media to share news of the first peripheral cases using its Seismiq system. Boston Scientific President, Peripheral Vascular, Catherine Jennings, wrote on LinkedIn that the company is "celebrating an important milestone" with the completion of the first peripheral cases using the intravascular … [Read more...] about Boston Scientific reports first peripheral cases in Seismiq IVL rollout
Amplifi Vascular wins FDA breakthrough nod for vein dilation system
Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System. The St. Louis-based company also picked up Category B assignment from the Centers for Medicare & Medicaid Services (CMS). It said the two nods mark "a pivotal step" in its mission to address critical healthcare needs. Amplifi … [Read more...] about Amplifi Vascular wins FDA breakthrough nod for vein dilation system
Boston Scientific wins FDA nod for Farapoint PFA catheter
A Boston Scientific (NYSE:BSX) executive said on social media that the company received FDA approval for its Farapoint pulsed field ablation (PFA) catheter. SVP and President of Electrophysiology, Nick Spadea-Anello, posted on LinkedIn to congratulate the company for receiving FDA approval for Farapoint. He noted that the approval "closely … [Read more...] about Boston Scientific wins FDA nod for Farapoint PFA catheter
Luma Vision, CardioFocus complete 4D-guided AFib ablation procedures in clinical study
Luma Vision announced that it completed 15 AFib ablation procedures as part of a clinical study in collaboration with CardioFocus. Dublin, Ireland-based Luma Vision said the study aims to, in part, evaluate the ability of its Verafeye 4D navigation and imaging platform. The company designed Verafeye to guide catheter ablation therapy. That … [Read more...] about Luma Vision, CardioFocus complete 4D-guided AFib ablation procedures in clinical study
