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Helius Medical closes over-allotment, brings round to $8.1 million
Helius Medical Technologies (OTC:HSDT) said yesterday it closed an over-allotment option for its most recent round of financing, bringing the total raised up to $8.1 million (CAD $10.3 million).
The Newton, Penn.-based company said it floated an additional 1.1 million units at 79¢ (CAD $1.00) in the over-allotment, raising an extra $857,083 for the round. The offering officially closed on April 18.
Each unit sold consisted of a Class A share and a half-share warrant with an exercise price of roughly $1.18 (C$1.50), the company said in a press release.
A commission of $51,424 was paid to Mackie Research Capital who acted...
Source: Mass Device - May 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Helius Medical Technologies Source Type: news
The Health Innovations Scholars Program: A Model for Accelerating Preclinical Medical Students Mastery of Skills for Leading Improvement of Clinical Systems
Dramatic changes in health care require physician leadership. Efforts to instill necessary skills often occur late in training. The Heath Innovations Scholars Program (HISP) provided preclinical medical students with experiential learning focused on process improvement. Students led initiatives to improve the discharge process for stroke patients. All students completed an aptitude survey and Quality Improvement Knowledge Assessment Test (QIKAT) before and after the program. Significant improvements occurred across subject areas of leadership (18.4%, P < .001), quality and safety (14.7%, P < .001), and health care sy...
Source: American Journal of Medical Quality - June 30, 2016 Category: Health Management Authors: Sweigart, J. R., Tad-y, D., Pierce, R., Wagner, E., Glasheen, J. J. Tags: Articles Source Type: research
Pivotal trial pits St. Jude Medical ’ s Amplatzer Amulet anti-stroke device against Boston Scientific ’ s Watchman
St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation.
The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to a stroke. The FDA approved a similar device made by Boston Scientific (NYSE:BSX), the Watchman implant, in March 2015; St. Jude’s 1,600-patient IDE trial will compare the Amplatzer Amulet to the Watchman in patients with non-ventricular arrhythmias.
The primary safety endpoint is ...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Wall Street Beat Boston Scientific St. Jude Medical 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
Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday the Centers for Medicare and Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with the company’s Enroute transcarotid neuroprotection and stent system.
The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems indicated for transcarotid procedures. The devices are also required to be entered into the national TCAR Surveillance Project, Sunnyvale, Calif.-based Silk Road Medical said.
The company said it...
Source: Mass Device - September 16, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Stents Vascular Centers for Medicare and Medicaid Services (CMS) Silk Road Medical Inc. Source Type: news
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes.
“Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news
St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots.
The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news
Stryker ’ s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.
Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA.
The federal watchdog reviewed the order, and said that on September 2 it issued an order to reclassify the device types, given the generic name of neurovascular mechanical thrombectomy devices for ischemic stroke treatment, as Class II.
In relabeling the devices, the FDA identified 5 possible risks, including adverse tissue rea...
Source: Mass Device - December 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Concentric Medical Inc. Stryker Source Type: news
Claret Medical wins a date with the FDA for Sentinel TAVR device
An FDA advisory panel is slated to review next month the Sentinel embolic protection device made by Claret Medical, following the company’s bid for de novo clearance last fall.
The federal watchdog’s Circulatory System Devices Panel scheduled a hearing for Feb. 23 to review the clearance bid for Sentinel, which is designed to use a pair of temporary arterial filters during transcatheter aortic valve replacement to trap blood clots before they get to the brain.
Data from a pivotal trial in high-risk patients, released in November 2016, failed to meet the primary efficacy endpoint, although Sentinel met th...
Source: Mass Device - January 10, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Claret Medical Inc. Source Type: news
FDA panel supports Claret Medical ’ s Sentinel, despite efficacy questions
The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during trans catheter aortic valve replacement procedures to trap blood clots before they reach the brain.
Members of the panel said that while current efficacy data on the device was not strong enough to assess its ability to prevent stroke, the device may be worth allowing due to its safety profile and the possibl...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Source Type: news
FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.
“For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news
Medical News Today: Brain hemorrhage: Causes, symptoms, and treatments
A brain hemorrhage is bleeding in the brain. It is life-threatening medical condition, and it is essential to receive medical treatment right away.
Source: Health News from Medical News Today - April 24, 2017 Category: Consumer Health News Tags: Stroke Source Type: news
Claret Medical wins de novo FDA nod for Sentinel TAVR filter
Claret Medical said today that the FDA granted de novo clearance for its Sentinel device, which is designed to trap blood clots before they reach the brain during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. Although the device met its primary safety endpoint in a pivotal study (major adverse cardiac and cerebrovascular events at 30 days), it missed the primary efficacy endpoint of reduction in median new lesion...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Wall Street Beat Claret Medical Inc. De Novo Clearance Source Type: news
MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism.
The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news
Baylor Scott & White Medical Center - Grapevine Implements Smartphone Technology To Improve Communications for Emergency Conditions
Baylor Scott & White Medical Center – Grapevine has implemented a new technology called Pulsara to improve the communication technologies and protocols for patients experiencing symptoms of stroke or heart attacks.
The Pulsara platform runs as an application on the smartphones of the medics in the field and each member of the care team at the hospital. The app allows paramedics or EMTs in the field who recognize a stroke or STEMI to simply tap a button on their smartphones, which then notifies everyone on the hospital team that an ambulance is on its way with the critical patient. As the paramedic enters more informa...
Source: JEMS: Journal of Emergency Medical Services News - July 5, 2017 Category: Emergency Medicine Authors: Pulsara Tags: Operations Industry News Source Type: news
