Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system. The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. CellFX nsPFA’s percutaneous electrode system features a percutaneous needle […]
iRhythm closes offering worth more than $660M
iRhythm announced today that it closed an offering of senior notes worth gross proceeds of $661.25 million. The San Francisco-based cardiac monitor maker said earlier this week that it intends to offer $450 million in convertible senior notes. Approximately 17 hours later, it upsized that offering to a base of $575 million. San Francisco–based iRhythm […]
FDA clears Getinge’s cardiovascular surgery offering, company lanches new table, light in U.S.
Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools. The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions. Getinge said it designed the system with customer centricity top-of-mind. It hopes […]
LivaNova prices $300M offering
LivaNova announced that it priced an offering of convertible senior notes worth $300 million in total. The company plans to offer the notes, due 2029, to qualified institutional buyers. LivaNova also granted initial purchasers an option to purchase up to an additional $45 million in notes. This option comes within a 13-day period beginning on […]
Endotronix has positive pulmonary artery sensor data
Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary hypertension with associated heart failure. Paris-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina. Dr. Marat Fudim and […]
Stereotaxis submits Magic ablation catheter for U.S., European approval
Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval. The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the […]
Haemonetics agrees to acquire esophagus-protecting device maker Attune Medical
Haemonetics announced today that it entered into an agreement to acquire Attune Medical. Boston-based Haemonetics agreed to buy Attune for an upfront cash payment of $160 million. The deal also includes additional contingent consideration based on sales growth in the three years following the consummation of the acquisition. These additional payments also hinge on other […]
BD initiates IDE trial of stent for treating peripheral arterial disease
BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
iRhythm proposes $450M offering
iRhythm announced today that it intends to offer $450 million in convertible senior notes. San Francisco–based iRhythm plans to offer the notes — due 2029 — to qualified institutional buyers. It intends to grant initial purchasers a 13-day option to buy up to an additional $67.5 million in notes. The notes will be senior, unsecured […]