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MassDevice.com +3 | The top 3 medtech stories for November 12, 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. SurgiQuest files for $75m IPO
SurgiQuest this week registered for an initial public offering estimated at $75 million.
Milford, Conn.-based SurgiQuest makes the AirSeal device for use in minimally invasive abdominal surgeries. AirSeal is designed to insufflate the rectum and provide continuous...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer.
Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset of the patients who currently would be eligible for the device under the FDA-approved label,” or patients at high risk for stroke and bleeding and/or contraindicated to long-term warfarin use.
“Whi...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement 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
Axinesis wins CE Mark for robotic rehab device
Axinesis said today it won CE Mark approval in the European Union for its REAPlan medical interactive robot device designed to rehabilitate impaired upper limbs in stroke victims and children with cerebral palsy.
The Belgian company’s REAPlan combines robotics and “therapeutic gaming” to improve rehabilitation of impaired upper limbs, and offers automated personalized assistance of arm movements, Axinesis said.
“This is an important milestone in our mission to provide state-of-the-art technologies dedicated to the rehabilitation of brain-injured patients. The continual requests from customers for pr...
Source: Mass Device - February 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Regulatory/Compliance Robotics Axinesis 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
Edwards Lifesciences hits all-time high on Sapien 3 study
Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend.
Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lan...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Wall Street Beat American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 5, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Results from the Propel all-comers trial comparing Medtronic‘s Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.
“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMo...
Source: Mass Device - April 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Biotronik Source Type: news
FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.
The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with dr...
Source: Mass Device - April 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Food & Drug Administration (FDA) St. Jude Medical Source Type: news
J & J ’ s Codman Neuro inks distro deal with InNeuroCo
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it inked an exclusive U.S. and European distribution deal with InNeuroCo for its intermediate catheters designed for the minimally invasive treatment of hemorrhagic stroke.
Codman Neuro made the announcement at the Society of NeuroInterventional Surgery’s 13th annual meeting, Codman Neuro said.
“Intermediate catheters are increasingly used by neurovascular specialists to facilitate the delivery of other devices, including stents and thrombectomy devices for the treatment of stroke. This agreement with InNeuroCo demonstrates our commitment to ne...
Source: Mass Device - August 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Distribution Neurological Codman Neuro Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 1, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman
St. Jude Medical said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, whic...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
FDA approves Concentric Medical ’ s Trevo clot retrievers
The FDA said today it granted expanded approval to 2 Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.
The indications expand the previously won clearance for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who could not receive t-PA or for patients who didn’t respond to t-PA therapy.
“This is the first time FDA has allowed the use of these devices alongside...
Source: Mass Device - September 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Catheters Food & Drug Administration (FDA) Regulatory/Compliance Concentric Medical Inc. Stryker Source Type: news
J & J ’ s Codman Neuro picks up Pulsar Vascular
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it picked up Pulsar Vascular, which produces the PulseRider device for treating brain aneurysms, for an undisclosed amount.
The PulseRider is designed to shore up the blood vessels around wide-necked aneurysms at or near a bifurcation of the basilar tip or carotid terminus and facilitate the implantation of an embolization coil, without obstructing blood flow through the vessels, according to the company’s website.
Codman Neuro said the acquisition will complement its portfolio of products covering hemorrhagic and ischemic stroke.
“There is a signif...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Vascular Codman Neuro Johnson and Johnson Pulsar Vascular Source Type: news
4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression.
Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news
Stable blood sugar linked to heart stent outcomes
Patients with type 2 diabetes and a coronary stent are at lower risk for heart attack and stroke if they maintain good blood sugar control, according to a recent study.
“Although intensive glucose control had no benefit on the rate of major cardiovascular events in previous studies, our data suggest that strict glucose control after PCI (heart catheterization) can improve long-term clinical outcomes in diabetic patients,” Dr. Joo-Yong Hahn from Samsung Medical Center in Seoul said in an interview with Reuters Health.
Researchers looked at 980 patients with type 2 diabetes and a stent, examining long-term bloo...
Source: Mass Device - April 21, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials Diabetes Stents Source Type: news
