Genetic testing cut adverse events in heart patients
Personalized genetic testing led to a 34% decrease in the number of patients...Read more on AuntMinnie.comRelated Reading:
USPSTF advises against carotid artery stenosis screening
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USPSTF opens review of carotid stenosis screening
Coronary CTA beats stress test for changing lifestyles (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - August 27, 2020 Category: Radiology Source Type: news
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers
Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million.
The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock.
Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR.
“The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news
Silk Road Medical upsizes IPO
Silk Road Medical today boosted the size of its pending initial public offering to as much as $120 million.
When it registered the IPO in March, Silk Road said it could fetch as much as $86 million. But last week the Sunnyvale, Calif.-based company cut the range, saying it planned to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Today Silk Road said it plans to offer 6 million shares at $19 to $20 a piece, which would deliver gross proceeds of $114 million to $120 million. The company developed the Enroute transcarotid stent and neuroprotection system to treat c...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Wall Street Beat Silk Road Medical Inc. Source Type: news
Silk Road Medical sets downsized range for IPO
Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint.
The Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system is designed to treat carotid artery blockages before they cause a stroke. When it registered the IPO earlier this month, Silk Road said it could fetch as much as $86 million. But yesterday the company said it plans to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Silk Road has said it plans to use the cash to expand its sales force and ope...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Silk Road Medical Inc. Source Type: news
FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection.
Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January.
A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said.
“We are thrilled to have achieved this milestone for the first of several devices Conteg...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news
Video: Carotid angioplasty and stenting
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - July 14, 2018 Category: Consumer Health News Source Type: news
Contego Medical launches Neuroguard IEP trial
Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis.
The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said.
“We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a ...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Contego Medical Source Type: news
7 medtech stories we missed this week: Sept. 22, 2017
[Image from unsplash.com]From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning.
1. FDA clears Covalon’s MediClear OTC surgical film-drape
Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion site. The ...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Diagnostics Food & Drug Administration (FDA) Laboratory Instruments/Laboratory Supplies mHealth (Mobile Health) Research & Development Vascular Bioventus LLC Contego Medical Covalon Technologies Getinge Guerbe Source Type: news
Contego Medical wins CE Mark for Vanguard IEP angioplasty system
Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region.
The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an over-the-wire design with a sheathless integrated 150-micron pore filter distal for the angioplasty balloon.
“The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease. This device wil...
Source: Mass Device - April 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Regulatory/Compliance Vascular Contego Medical Source Type: news
TCT 2016: The best of the rest
The annual Transcatheter Cardiovascular Therapeutics conference went down in Washington, D.C., this week, with late-breaking study results beginning Oct. 29.
After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therapies conference.
Below is a roundup of miscellaneous releases from the conference:
Freudenberg Medical launches new products
Freudenberg M...
Source: Mass Device - November 3, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Catheters Clinical Trials TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 81
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 423
Total On Hold: 176
Summary of All PMA Submissions
Originals: 3
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163.1
FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Contego Medical Announces Positive Clinical Data for Paladin(R) System, the First Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Data presented at the Leipzig Interventional Course (LINC) demonstrates breakthrough treatment for Carotid Artery Disease
RALEIGH, N.C., Jan. 26, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical, an innovator in developing next generat... Devices, InterventionalContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 26, 2016 Category: Pharmaceuticals Source Type: news
Contego Medical Announces European Commercialization of the Paladin(R) Carotid Post-Dilation Balloon with Integrated Embolic Protection(TM) Technology
Presenting at the Leipzig Interventional Course (LINC) from January 26th-29th in Leipzig, Germany.
RALEIGH, N.C., Jan. 14, 2016 -- (Healthcare Sales & Marketing Network) -- Contego Medical today announced the European commercialization of the Paladin&r... Devices, Interventional, Product LaunchContego Medical, Paladin System, angioplasty balloon, Embolic Protection (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 14, 2016 Category: Pharmaceuticals Source Type: news
VIVA 2015 Roundup: Medtronic touts Valiant stent graft, PAD stent-treatment data
Medtronic (NYSE:MDT) this week presented data from 2 studies of its stent systems and announced a new study of its In.Pact Admiral drug-coated balloon. The announcements were made at the VIVA physicians annual conference in Las Vegas, Nev.
The Fridley, Minn.-based medical giant presented data from a 2-year clinical trial of its Valian Captivia thoracic stent graft system for treating type B aortic dissections, reporting safety and efficacy at 2-years.
Data from the 2-year follow up of the 35-patient FDA approved IDE trial reported no post-index procedure ruptures or conversions, device related adverse events or loss of ...
Source: Mass Device - November 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abbott Avinger Boston Scientific C.R. Bard Cook Medical Medtronic Spectranetics Corp. TriVascular TVA Medical Vascular Dynamics Vascular Interventional Advances (VIVA) Source Type: news
Medtech approvals: FDA releases May 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 51
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 26
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 547
Total Active: 379
Total On Hold: 168
Summary of All PMA Submissions
Originals: 1
Supplements: 62
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 109.5
FDA Time: 86.4 D...
Source: Mass Device - August 6, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
