EKOS Corporation has gained U.S. FDA clearance to market its EkoSonic® Endovascular System for the ultrasound-facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE).
Thoracic/Respiratory
Pulmonx Updates on Clinicals
Interventional Pulmonology company Pulmonx has announced that multiple clinical abstracts examining the diagnostic and therapeutic utility of its Chartis Pulmonary Assessment System and Zephyr® Valve have been presented at the American Thoracic Society International Conference.
OPKO Acquires Israeli Company Inspiro Medical, with its Dry Powder Inhaler
OPKO Health, Inc. has entered into a definitive agreement to acquire Israeli medical device company Inspiro Medical Ltd. and its Inspiromatic™, a “smart” easy-to-use dry powder inhaler with several claimed advantages over existing devices.
Poster Points to Improved Lung Function with Pulmonx Endobronchial Valve Therapy
Interventional Pulmonology company Pulmonx points us at a poster about its Zephyr® Endobronchial Valve (EBV). The poster was featured at the 18th World Congress for Bronchology and Interventional Pulmonology (WCBIP) in Kyoto, Japan.
FDA Clearance for Breathe Technologies’ NIOV System for use with Compressed Gas
Breathe Technologies, Inc. has announced the U.S. FDA 510(k) clearance of its Non-Invasive Open Ventilation (NIOV) System, opening up the potential for it to be used with a compressed air supply for non-oxygen dependent patients.
FDA Clears Covidien’s Puritan Bennett™ 980 Ventilator
Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.
EndoGastric Solutions Coughs Up but Admits No Wrongdoing
Endoluminal gastroesophageal reflux disease device company EndoGastric Solutions® (EGS) has reached a civil settlement with the U.S. Department of Justice over alleged misuse of procedure codes that will cost it $5.25 million.
Cook Medical Claims First with EchoTip® ProCore™ Endobronchial Ultrasound Needle with Biopsy Capability
Cook Medical’s EchoTip® ProCore™ Endobronchial Ultrasound Needle gives physicians the ability to retrieve both cell and tissue samples from lymph nodes or tumors in the pulmonary area.
Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections
Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.
Study Says Digital Chest Drains Shorten Stay and In-dwelling Chest Tube Duration
A new study, presented at the 50th holding of the Society of Thoracic Surgeons in Orlando Florida this week, points to improved management of patients when employing digital chest drains, as compared with traditional methods.
Bigging Up the World’s Smallest CPAP machine
Human Design Medical, LLC is about to release the most versatile cpap device ever. The company says its Z1™ is a new innovative cpap device that is significantly lighter, smaller, quieter and more integrated than other cpap machines and is changing the rules of design, portability and user experience in the cpap industry.
Lung Resection Data Points to Better Outcomes for daVinci than Open Surgery
It’s no surprise at all that restrospective data from lung resection cases shows improved outcomes for minimally invasive techniques compared with open surgery. Intuitive can’t yet claim its daVinci system outperforms VATS resection though, as data is not statistically significant.
Covidien’s New Clinical Data is a Statement of Intent for its Peripheral Arterial Disease Business
Covidien has released positive final results from its DURABILITY II study and promising preliminary data from its DEFINITIVE AR Peripheral Artery Disease (PAD) trial involving some of its technologies. The results are sure to fuel its ongoing push into the peripheral vascular therapy area.
First for Gore as FDA Approves Prosthesis for Endovascular Repair of Aortic Dissection
W. L. Gore & Associates has gained FDA approval for its Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication and is designed for multiple thoracic etiologies.
European Clot Management Device Market To Exceed $170 Million By 2022
According to global market intelligence company Millennium Research Group, the European market for clot management devices will see moderate growth through 2022. Although a number of segments are mature, fast-growing segments such as endovascular treatments for acute ischemic stroke and venous thromboembolism underpin the growth forecast.
Teleflex Acquires Airway Management Device Company Ultimate Medical
Following the announcement that it is to buy Israeli microlaparoscopy business Eon Surgical, Teleflex has now snapped up the assets of airway management device innovator Ultimate Medical.