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Renal denervation programme to be discontinued
Balloons : 27 January, 2014
Poor market development in renal denervation has caused Covidien to exit the programme prior to completion
Journal publishes balloon dilation study results
Balloons : 24 September, 2013
Trial results have been published which show the effectiveness of balloon dilation as an alternative to surgery for patients suffering from chronic sinusitis
Balloon sinus dilation device with LED light fibre
Balloons : 13 September, 2013
Surgey based balloon sinus dilation now possible without external light sources with the inclusion in the Xpress tool of an LED light fibre
Structural heart device successfully used in Malaysia
Balloons : 02 September, 2013
Patients in Malaysia have been undergoing treatment with a minimally invasive ventricular partitioning device supplied by CardioKinetix
Medtronic submits first PMA module for IN.PACT Admiral drug-eluting balloon
Balloons : 19 August, 2013
Medtronic is submitting the company's first pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon.
Study indicates benefits of balloon sinus dilation compared with traditional sinus surgery for chronic sinusitis
Balloons : 26 July, 2013
Results from a randomized study demonstrate the benefits of non-surgical balloon sinus dilation procedures compared to traditional sinus surgery for chronic sinusitis patients.
Sanford Aberdeen Medical Center performs first robotic-assisted stent placement in acute heart attack patient
Balloons : 19 July, 2013
Sanford Aberdeen Medical Center in Aberdeen, South Dakota, USA, became the first hospital to perform a Robotic Angioplasty for a patient with an acute heart-attack, achieving a far better door-to-balloon time than the national standard.
Cook Medical launches new wire guided oesophageal balloon to treat GI strictures
Balloons : 21 June, 2013
Cook Medical is making the company's Hercules 3 Stage Wire Guided Esophageal Balloon available to otolaryngologists to treat patients with gastrointestinal (GI) strictures.
Medtronic to submit first module of US approval application for novel peripheral angioplasty device to FDA
Balloons : 04 June, 2013
Medtronic declares that enough patients have been enrolled in the company's clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company's US regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.
Entellus Medical launches multi-sinus dilation tool with light fibre
Balloons : 25 January, 2013
Entellus Medical is launching the company's XprESS LoProfile Multi-Sinus Dilation Tool which features a reduced profile that is designed to more easily navigate tight sinus spaces and facilitate quick and easy dilation of multiple sinus drainage paths, allowing physicians to potentially treat more patients with in-office procedures or reduced OR time.
Covidien launches therapeutic device for treatment of resistant hypertension
Balloons : 17 January, 2013
Covidien is launching the OneShot Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.
Covidien acquires CV Ingenuity
Balloons : 14 January, 2013
Covidien completes the acquisition of CV Ingenuity.
Covidien plans to acquire CV Ingenuity
Balloons : 27 December, 2012
Covidien declares a definitive agreement to acquire CV Ingenuity with the companies expecting to complete the acquisition in the first calendar quarter of 2013.
US FDA panel reclassifies intra-aortic balloon pumps to A Class II designation in certain indications
Balloons : 14 December, 2012
MAQUET Cardiovascular, the leader in intra-aortic balloon (IAB) therapy, reveals that the Circulatory System Devices Panel of the US Food and Drug Administration (FDA) recently voted to support the Agency's reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval).
First-in-Human study starts for valvuloplasty scoring balloon for critical aortic valve stenosis
Balloons : 18 October, 2012
AngioScore successfully initiates enrollment in the 'CardioSculpt' Valvuloplasty Scoring Balloon for Critical Aortic Valve Stenosis First-in-Human (FIH) Study.
Vention Medical launches online store for heat shrink tubing, multi-layer tubing, and balloons
Balloons : 18 October, 2012
Vention Medical launches a new online store to respond to the need for faster, more timely delivery of its medical grade heat shrink tubing, multi-layer tubing, and medical balloons for medical device manufacturers.
Creganna-Tactx Medical completes acquisition of ABT
Balloons : 08 October, 2012
Creganna-Tactx Medical acquires ABT Medical which is a company that designs and manufactures medical balloons for minimally invasive devices serving a global portfolio of medical device companies.
IABP-SHOCK II clinical trial reveals results for cardiogenic shock
Balloons : 29 August, 2012
MAQUET Cardiovascular reveals 30-day results from the large, randomized, multicentre IABP-SHOCK II clinical trial in patients with acute myocardial infarction (AMI) who were in cardiogenic shock and undergoing early revascularization.
Angioslide completes first successful below-the-knee procedures in the USA
Balloons : 13 July, 2012
Angioslide deploys a 3X100mm PROTEUS device for treating Peripheral Artery Disease in below-the-knee (BTK) vasculature at Community Hospital in Munster, Indiana, USA.
Peripheral vascular Paclitaxel releasing balloon reports positive efficacy results
Balloons : 22 May, 2012
Six-month results from the BIOLUX P-I study for the Biotronik Passeo-18 Lux Paclitaxel Releasing Balloon, demonstrating excellent safety and efficacy results according to a paper presented at the EuroPCR 2012 congress by Dr Andrej Schmidt, Chief Angiologist at Herzzentrum/Park- Krankenhaus, Leipzig, Germany.
Angioslide receives FDA 510(K) clearance for new below the knee device
Balloons : 07 May, 2012
Angioslide receives FDA 510(K) clearance for the company's new 3 X 100mm PROTEUS device for treating Peripheral Artery Disease in below the knee (BTK) vasculature.
Medtronic begins landmark US drug-eluting balloon study
Balloons : 17 April, 2012
Medtronic is starting the Medtronic IN.PACT SFA II study, the company's first US clinical trial for its line of IN.PACT drug-eluting balloons.
Blue Medical releases new drug eluting balloon
Balloons : 22 March, 2012
Blue Medical is launching globally the company's CE approved drug eluting balloon (DEB) Protege as well as its CoCr stent on DEB Pioneer.
Biotronik reports positive results for Pantera Lux Paclitaxel releasing balloon
Balloons : 14 November, 2011
Six-month results from the DELUX registry and 12-month results from the PEPPER study, both demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon, were presented on at the Transcatheter Cardiovascular Therapeutics (TCT 2011) conference by Dr Ralph Toelg, MD, Segeberger Heart Center Clinic, Bad Segeberg, Germany, and Prof Christoph Hehrlein, MD, University Medical Center, Freiburg, Germany, respectively.
11-gauge vertebral balloon targets spinal fracture treatment market
Balloons : 30 March, 2011
CareFusion is launching an 11-gauge vertebral balloon for use in the spinal fracture treatment market.
Trial indicates higher survival rate after four years using balloon kyphoplasty
Balloons : 24 February, 2011
Medtronic unveils the results of a retrospective claims-based data analysis suggesting that a patient group of those over 65 in the USA whose spinal fractures were treated with minimally invasive surgery had a higher survival rate up to four years after treatment than a patient group that did not have surgery.
Trial results released for Kyphon Balloon Kyphoplasty comparison study
Balloons : 18 February, 2011
Medtronic reveals results from the first randomized, controlled trial comparing Kyphon Balloon Kyphoplasty with non-surgical care in treating spinal fractures in cancer patients.
Mayo Clinic treats AF with minimally invasive freezing balloon technology
Balloons : 07 January, 2011
Mayo Clinic is the first in the USA to use the first minimally invasive freezing balloon technology for the treatment of atrial fibrillation (AF) approved in December by the US Food and Drug Administration.
Cardiac CryoAblation Catheter system receives US FDA approval
Balloons : 21 December, 2010
The US Food and Drug Administration (FDA) approves Medtronic’s Arctic Front Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF).
IBT receives FDA clearance to treat vertebral compression fractures
Balloons : 25 October, 2010
Medtronic receives US Food and Drug Administration clearance of the Kyphon Xpander II Inflatable Bone Tamp (IBT) for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty.
New curette maximises control when scraping or scoring bone in the spine
Balloons : 07 October, 2010
Medtronic launches the new Kyphon Express Curette for scraping or scoring bone in the spine, including during treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty.
Medtronic launches cement delivery system in Europe for balloon kyphoplasty
Balloons : 20 September, 2010
Medtronic is launching the KYPHON Cement Delivery System (CDS) in Europe, adding an innovative bone cement delivery option to its extensive KYPHON Balloon Kyphoplasty product portfolio for the treatment of vertebral compression fractures (VCFs).
CareFusion launches vertebral balloon to support kyphoplasty procedures
Balloons : 31 August, 2010
CareFusion announces the US launch of the AVAmax Vertebral Balloon, a minimally invasive device for use during kyphoplasty, a procedure for treating spinal compression fractures.
Boston Scientific expands balloon sizes of peripheral dilatation system
Balloons : 23 June, 2010
Boston Scientific adds 22 new balloon sizes to the PolarCath Peripheral Dilatation System, including balloon lengths of 120 and 150 mm.
Balloon device addresses kyphoplasty and vertebroplasty procedures
Balloons : 18 March, 2010
CareFusion is launching the AVAmax Vertebral Balloon, a minimally invasive device for use during kyphoplasty, a procedure for treating spinal compression fractures.
Cook Medical releases oesophageal balloon around the world
Balloons : 04 March, 2010
The Cook Medical Hercules 3 Stage Esophageal Balloon is released in the USA, Australia, Canada and Europe after receiving 510(k) clearance and CE Mark certification.
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