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Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week.
In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures.
Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
7 medtech stories we missed this week: Oct. 20, 2017
[Image from unsplash.com]From InspireMD’s distribution deal to RenalGuard touting a new study, here are seven medtech stories we missed this week but thought were still worth a mention.
1. InspireMD inks Chile distribution deal
InspireMD announced in an Oct. 12 press release that it has signed a distribution deal with CorpMedical Chile to distribute the MGuard Prime Embolic Protection System (EPS). The MGuard Prime EPS treats acute coronary syndromes like acute myocardial infarctions.
2. Medacta launches MiniMed hip stem
Medacta has launched its MiniMAX Hip System in the U.S., according to an Oct. 12 press release. ...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Implants Orthopedics Patient Monitoring Regulatory/Compliance Surgical Ultrasound Esaote Hill-Rom Holdings Inc. Honeywell InspireMD Medacta Source Type: news
Claret Medical raises $21m
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted this week.
The Santa Rosa, Calif.-based company is not seeking to raise any more funds in the round and has not yet stated how it plans to spend the funds it raised.
Money in the round came from 35 anonymous investors, according to the SEC filing, with the 1st sale noted on June 22.
Earlier this week, Claret Medical released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortali...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news
Russian study pits InspireMD ’ s CGuard device against Abbott ’ s Rx Acculink carotid stent
InspireMD (NYSE:NSPR) this week touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT).
The 100-patient trial is designed to compare the two devices in terms of neuroprotection and clinical superiority in subjects undergoing carotid endarterectomy, the Tel Aviv-based company said. Conducted at the Scientific Research Institute of Circulation Pathology in Novosibirsk, the study is led by Dr. Andrei Karpenko.
The primary endpoint is new ischemic areas in the brain 24 to 48 hours post-procedure and new lesion permanence at...
Source: Mass Device - October 12, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Stents InspireMD Stroke Source Type: news
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.
The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation.
“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Rapid Medical launches Tigertriever registry study
Neurovascular device maker Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever.
The Israel-based company touts the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
The newly launched European multi-center registry study looks to enroll patients in France and Switzerland, and will be the 1st to examine the use of the Tigertriever in a real-life setting. The company said it has enrolled its 1st patient in the trial at Switzerland’s Cantonal Hospital of Lucerne.
...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Stents rapidmedical Source Type: news
Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates.
The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said.
The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so.
“In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 15, 2017
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. FDA cuts could threaten medtech innovation: Here’s why
The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Studies support anti-stroke PFO closure devices from Abbott, Gore
Sykes and Clark; licensee BioMed Central Ltd.
A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients.
Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurr...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news
Cheetah Medical raises $12m
Cheetah Medical said today it raised $11.8 million in an expanded Series C funding round as it looks to grow its US footprint.
Financing was provided by existing investors including MVM Life Science Partners, Springfield Investment Management, Fletcher Spaght Ventures, HighCape Partners and Robert Basch Venture Capital, the Newton, Mass.-based company said.
Cheetah Medical provides noninvasive hemodynamic monitoring devices and systems, including its Cheetah Nicom and Starlin SV technologies, which operate around a proprietary algorithm designed to allow physicians to examine a patient’s full hemodynamic profile.
&#...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cheetah Medical Source Type: news
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure.
The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date.
Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news
Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial.
Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down on its renal denervation assets. News of th...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Wall Street Beat Medtronic Renal Source Type: news
FDA approves Malin ’ s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug.
The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device.
“This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel,” Hourglass co-developer George Wallace, said in prepared remarks.
“The Hourgl...
Source: Mass Device - August 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Regulatory/Compliance Vascular malincorp Source Type: news
MassDevice.com +5 | The top 5 medtech stories for August 18, 2017
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. Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new ...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new multi-center study.
Researchers at the University of Warwick’s WMG, the Baker Institute and Monash University reported that when they increased the wavelength of light currently used to visualize athereosclerotic plaques, they were able to selectively identify rupture-prone deposits, which can lead to blood clots, heart attacks and strokes.
Data from a study of the technique was published in the journal Nature Communications.
Current imaging techniques are able to identify c...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Research & Development Source Type: news
