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Total 237 results found since Jan 2013.
Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers.
Broomfield, Colo.-based Colibri is running a 1st-in-human trial of the transcatheter aortic valve replacement it’s developing, a pre-mounted, pre-crimped and pre-packaged device that’s designed to be shipped ready to use, according to its website.
Colibri has said that patients enrolled in the study showed no observed stroke, no pacemaker implantations, virtually no paravalvular leak and a high retained average effective orifice ...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Colibri Heart Valve Source Type: news
ECRI, LSE partner for medical device pricing study
The ECRI Institute said earlier this month it inked a partnership deal with the London School of Economics and Political Science’s LSE Health and Social Care group.
The Plymouth Meeting, Penn.-based institute said both groups will collaborate on a project that seeks to examine medical device pricing across different countries.
“Reducing costs in the healthcare system is critically important for hospitals and health systems worldwide. We anticipate that our partnership with LSE will yield the kind of research results that are needed to make device pricing more transparent,” ECRI European operations veep Da...
Source: Mass Device - March 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Research & Development ECRI Institute Source Type: news
Corvia Medical wins FDA nod for trial, inks exclusive buyout deal with strategic backer
Corvia Medical said today that it won an investigational device exemption from the FDA for a clinical trial of its cardiac implant designed to treat diastolic heart failure and inked a deal with an unnamed strategic investor that includes an exclusive buyout option.
Corvia’s transcatheter InterAtrial shunt device is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria, according to Corvia’s website.
Tewksbury, Mass.-based Corvia said the 100-patient Reduce Lap-HF I study is a prospective, multicenter, randomized controlled trial. The primary ...
Source: Mass Device - March 7, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Mergers & Acquisitions Corvia Medical Source Type: news
FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population.”
Earlier this month, the FDA granted an expanded indication for the CoreValve devices for patients with end-stage renal disease and low-grade, low-flow aortic stenosis.
The post FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R appeared first on MassDevice.
Source: Mass Device - February 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug alteplase, according to a meta-analysis of 4 previous trials of the device.
The transcatheter Solitaire device uses a stent-like device to trap and retrieve a blood clot in the brain in cases of ischemic stroke. Researchers from the 4 trials – Swift Prime, Revascat, Extend-IA and Escape – pooled their data to examine the results from 787 patients, randomized to either thrombectomy with the Solitaire device (401) or stan...
Source: Mass Device - February 18, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Neurological Vascular Medtronic Stroke Source Type: news
Medtronic wins expanded PMA for CoreValve
The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis.
Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems.
The changes to the labeling were approved based on Medtronic’s CoreValve U.S. expanded use study of high and very-high-risk subjects at need for aortic valve replacements, according to an email FierceMedicalDevices received from a Medtronic spokesperson.
Data from theÂ...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Contego touts post-market data for Paladin balloon
Contego Medical today released preliminary data from a post-market registry study of its Paladin carotid post-dilation balloon that showed improved patient outcomes in individuals treated with the system, and no adverse events.
The device, which come with integrated embolic protection, is designed to provide embolic protection during post-dilation in carotid stent procedures, the Raleigh, N.C.-based company said.
“These preliminary results are consistent with previous findings and validate the Paladin System as a new meaningful technology in the carotid market. My experience in the post-market registry has been very ...
Source: Mass Device - January 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Contego Medical Source Type: news
VasSol touts data on MRI-based blood flow measurement
VasSol said last week that results from a trial of its Nova non-invasive optimal vessel analysis showed that the device was able to identify critical trial patients at higher risk of recurrent stroke. The results from the study were published in the JAMA Neurology journal.
Results from the 6-year, multi-center Veritas trial indicated that patients who experience a stroke in the back of their brain, and continue to have reduced blood flow to the area, have a higher risk of having another stroke within 2 years.
“Nova is the only technology that can visualize and quantify the volume, speed and direction of blood flow...
Source: Mass Device - January 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials Diagnostics Software / IT VasSol Source Type: news
Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve.
The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption for the Partner III trial is designed to evaluate the Sapien 3 TAVR in patients with a low mortality risk from open surgical valve replacement, the Irvine, Calif.-based company said.
“If this trial is successful, it will allow heart teams to choose a treatment ap...
Source: Mass Device - January 15, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line.
Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombo...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news
MassDevice.com +3 | The top 3 medtech stories for December 15, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman t...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news
Biotronik launches CLS-equipped pacer trial for treating syncope
Biotronik said today it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope.
Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said.
“While not fatal, recurrent syncope is quite dangerous and seriously compromises the patient’s quality of life. Previous studies have provided contradictory results regarding the benefit of cardiac pacing in syncope, and the current European Society of Cardiology...
Source: Mass Device - December 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Clinical Trials Biotronik Source Type: news
Biotronik launches trial of CLS AF algorithm
Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm.
The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial fibrillation compared to those without the system.
“AF is a huge clinical challenge, affecting over 20 million patients in Europe and the US alone. I am very excited to begin this groundbreaking trial. We hope to demonstrate that the physiological h...
Source: Mass Device - December 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Implants Software / IT Biotronik Source Type: news
