Akura Medical, a Shifamed portfolio company, today announced the closing of a $35 million Series B financing round. Los Gatos, California-based Akura develops a differentiated approach to address the challenges of venous thromboembolism (VTE). The company earmarked the funds for supporting its FDA 510(k) clearance submission for the Akura mechanical thrombectomy platform. Other uses include […]
Vascular
Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B
MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing payment totals $200 million, with achievement milestones […]
PercAssist treats first patient in heart failure support trial
PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study. The study evaluates PercAssist’s minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients. Principal investigator Dr. Petr Neuzil completed the first case at the Na Homolce Hospital in Prague, Czech Republic. Also involved were […]
FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system. The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures. According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — […]
Inspira to unveil new line of cardio-pulmonary bypass devices
Inspira Technologies (Nasdaq:IINN) announced today that it plans to unveil its new Inspira ART line of medical devices. Ra’anana, Israel-based Inspira plans to debut the devices at the Extracorporeal Life Support Organization (ELSO) Conference in Seattle. The line of devices includes the ART100 cardio-pulmonary bypass (CPB) device for patients undergoing CPB procedures. Additionally, the company has […]
Boston Scientific wins FDA nod for intravascular ultrasound system
Boston Scientific announced today that the FDA cleared its Avvigo+ multi-modality guidance system. The next-generation system provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures. Boston Scientific’s PCI business continues to […]
LivaNova president of cardiopulmonary is retiring
LivaNova announced today that Marco Dolci intends to retire from his position as president of the cardiopulmonary business unit. Dolci plans to retire by Dec. 31, 2023, continuing in his role to support the transition of responsibilities through the end of the year. The company appointed Franco Poletti to serve as interim GM of cardiopulmonary […]
CereVasc wins FDA IDE to expand eShunt trial
CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022. […]
Inspira submits cardio-pulmonary bypass device for FDA clearance
Inspira Technologies (Nasdaq:IINN) announced that it submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance. Ra’anana, Israel-based Inspira designed the system to transform external breathing, empowering breathing without lungs. The company anticipates potential clearance for the system in the first half of 2024. ART100’s bid for 510(k) clearance is backed by a comprehensive usability […]
FDA approves LimFlow chronic limb-threatening ischemia treatment
LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI). Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition. France-based LimFlow designed its TADV (transcatheter arterialization of […]
Shockwave picks Abbott Vascular exec Dr. Nick West as next chief medical officer
Shockwave Medical announced today that it appointed Dr. Nick West as its new associate chief medical officer. West’s appointment marks the start of an eventual transition. He reports to the current CMO, Dr. Keith Dawkins, with intentions to succeed Dawkins in mid-2024. “Dr. West brings to Shockwave a wealth of expertise in the interventional cardiology […]
