Abiomed (NSDQ:ABMD) shares fell approximately 13.1% yesterday despite the company announcing positive results from a pilot trial of its Impella CP heart pump that will clear the way for a pivotal that could nearly double the device’s total addressable market. The company announced on Sunday that a pilot study of its Impella CP, used to […]
Catheters
Cardiovascular Systems enters Chinese market through OrbusNeich deal
Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable […]
Trial shows BD balloon compares well with angioplasty for CLI
BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb […]
Nordson snaps up Clada Medical
Nordson (NSDQ: NDSN) said it has acquired Clada Medical Devices, a Galway, Ireland-based design and development contract manufacturer primarily focused on balloons and balloon catheters. The purchase will expand Nordson’s (Westlake, Ohio) balloon and balloon catheter capabilities with broader design, development and manufacturing capabilities, Nordson said in a statement. Terms of the deal were not disclosed. Get […]
FDA clears Transseptal Solutions’ TP Crosser transseptal access device
Medtech developer Transseptal Solutions said yesterday it won FDA 510(k) clearance for its TSP Crosser transseptal access system. The Israel-based company said that the TSP Crosser is an advanced transseptal puncture system which features a built-in steering mechanism and is designed for use in accessing the left atrium. The system is intended for use during […]
Switchback Medical debuts in Twin Cities metro
Medical device design startup Switchback Medical recently opened in a15,000-square-foot space in Maple Grove, Minn. The company offers capabilities in: Finished devices Balloon catheters Delivery systems Reinforced and steerable catheters Flex circuit technologies Nitinol components and frames Biomedical textiles Get the full story on our sister site, Medical Design & Outsourcing.
Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which […]
Adagio Medical launches OneShot+ cardio cryoablation cath
Cardiovascular cryoablation tech developer Adagio Medical said it launched its One Shot+ cryoablation catheter, and that the first patient has been treated with the device. The Laguna Hills, Calif.-based company said the newly cleared One Shot+ catheter is intended for pulmonary vein isolation and other continuous ablation lesions of non-pulmonary-vein targets for treating atrial fibrillation. […]
Ra Medical reaps $86m with IPO
Ra Medical (NYSE:RMED) said yesterday that its initial public offering brought in more than $86 million by the time it closed, including an underwriter’s option that added some $10 million to the take. The $17-per-share flotation of 4.5 million shares was bolstered by the 585,000-share over-allotment, for gross proceeds of $86.2 million. Carlsbad, Calif.-based Ra Medical, which makes the […]
Venus Medtech to acquire Keystone Heart
Chinese heart valve maker Venus Medtech said today it inked a deal to acquire cerebral embolic protection device maker Keystone Heart for an undisclosed amount. Tampa, Fla.-based Keystone Heart developed and produces TriGuard embolic protection devices, which are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce […]
Ra Medical sets range for $50m IPO
Ra Medical yesterday set the terms for its forthcoming initial public offering, which would fetch $50 million at the midpoint. The Carlsbad, Calif.-based company said it plans to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according […]