New Port Richey medical center performs first robotic-assisted procedure for arteries
The Medical Center of Trinity has successfully performed its first robotic-assisted angioplasty, which is the first for Tampa Bay and the first on Florida ’s west coast.
The robotic tools help the physicians treat patients with coronary artery disease.
Coronary artery disease, the plaque buildup that restricts blood flow in the arteries, is a widespread and life-threatening condition. Traditionally, percutaneous coronary intervention commonly kno wn as an ‘angioplasty,’ is the most common… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 3, 2019 Category: American Health Authors: Veronica Brezina-Smith Source Type: news
New Port Richey medical center performs first robotic-assisted procedure for arteries
The Medical Center of Trinity has successfully performed its first robotic-assisted angioplasty, which is the first for Tampa Bay and the first on Florida ’s west coast.
The robotic tools help the physicians treat patients with coronary artery disease.
Coronary artery disease, the plaque buildup that restricts blood flow in the arteries, is a widespread and life-threatening condition. Traditionally, percutaneous coronary intervention commonly kno wn as an ‘angioplasty,’ is the most common… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 3, 2019 Category: Biotechnology Authors: Veronica Brezina-Smith Source Type: news
Bursting Balloon Problem Prompts Cook to Recall Catheters
Cook Medical recalled certain lots of a balloon catheter used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries after receiving multiple complaints of balloons bursting below the rated burst pressure.
The company has determined that the problem affects the Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots manufactured between October 3, 2018, and December 17, 2018.
The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019, FDA said.Â&nb...
Source: MDDI - June 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Terumo ‘Tunes Up’ Orchestra BioMed with $30M Payment
Orchestra BioMed gained a powerful strategic partner to help push one of its lead products to the market.
Tokyo-based Terumo has agreed to give New Hope, PA-based Orchestra a $30 million up-front payment and an equity commitment of $5 million. Terumo said it will also make âsubstantialâ future clinical and regulatory milestone payments to Orchestra BioMed, plus a âstrong commitmentâ to finance and execute a global clinical program in collaboration with Orchestra to gain regulatory approval for the Virtue sirolimus-eluting balloon (SEB).
Orchestra said ...
Source: MDDI - June 14, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news
Terumo Enhances Coronary Interventional Product Portfolio By Securing Exclusive Global Rights to Orchestra BioMed's Virtue(R) Sirolimus-Eluting Balloon (SEB) through Global Strategic Partnership
First and only non-coated drug-eluting angioplasty balloon that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus
TOKYO, June 13, 2019 -- (Healthcare Sales & Marketing Network) -- Terumo Corporation (TSE: 4543), a leading... Devices, Interventional, Licensing Terumo, Orchestra BioMed, Virtue SEB, Sirolimus, drug eluting balloon (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 13, 2019 Category: Pharmaceuticals Source Type: news
Cardiac Arrest, Death During Elective PCI Concerningly Common Cardiac Arrest, Death During Elective PCI Concerningly Common
A European registry puts mortality at only about 50% if a patient arrests on the table during an elective percutaneous coronary intervention.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - June 4, 2019 Category: Cardiology Tags: Cardiology News Source Type: news
Open Heart Surgery Beats Stents for Multivessel Disease
FRIDAY, May 17, 2019 -- Coronary artery bypass graft (CABG) surgery may be a better treatment option than percutaneous coronary intervention (PCI) for most patients with more than one blocked heart artery, according to a study published online May 1... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 17, 2019 Category: Pharmaceuticals Source Type: news
Corindus Misses Expectations, But Still Embraced by Wall Street
Corindus Vascular Robotics missed earnings per share expectations by one cent, but Wall Street didnât seem to mind as shares of the medtech company, which was a 2015 MDEA finalist, soared on Wednesday.
At one-point shares were up by as much as 23%.
The surgical robotics maker reported 1Q19 EPS of $0.05 against the analyst estimate of $0.04. Revenue for 1Q19 was $3 million vs. the consensus estimate of $3.11 million. The Waltham, MA-based company recorded purchase orders for 11 CorPath GRX Systems, an increase of 83% compared to purchase orders received in 4Q18 and 267% growth compared to the purchase orde...
Source: MDDI - May 8, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Could Better Materials Lead to Better Outcomes with DCBs?
Boston University School of Medicine (BUSM) researchers are examining drug-coated balloon catheters at a microscopic level in hopes of producing more efficient alternatives for treating arterial disease.
The researchers are specifically looking at the coatings of the devices. Obstructive arterial disease is a clinical challenge affecting millions of people in the world. Devices such as stents and balloon catheters are the primary choice for treating these narrowed vessels. While the use of stents is beneficial in many cases, once implanted, they remain in the body permanently. Presence of such foreign bodies inside an arte...
Source: MDDI - May 3, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Cardiovascular Materials Source Type: news
Bringing Japanese Know-How to the Global Market:
A Visit to Shimadzu Medical Systems
TCROSS NEWS and its global partner, Angioplasty.Org, visited Shimadzu Corporation, a major Japanese company founded in 1875, to learn about its plans for future overseas business development of its angiography systems. We saw demonstrations of the Trinias Angiography System, the SCORE StentView software and more. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - April 24, 2019 Category: Cardiology Source Type: news
PCI Beneficial for All Categories of Older AMI Patients
WEDNESDAY, April 24, 2019 -- For older patients with acute myocardial infarction (AMI), percutaneous coronary intervention (PCI) is beneficial across age strata, according to a research letter published online April 23 in Circulation: Cardiovascular... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 24, 2019 Category: Pharmaceuticals Source Type: news
Non-Adherence to Antiplatelet Therapy After PCI Ups Risk of MACE in Anemic Patients Non-Adherence to Antiplatelet Therapy After PCI Ups Risk of MACE in Anemic Patients
In anemic patients who have undergone percutaneous coronary intervention (PCI), non-adherence to dual antiplatelet therapy (DAPT) - but not physician-recommended discontinuation - is associated with a higher risk of major adverse cardiovascular events (MACE) in the two years following the procedure, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 23, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news
FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday.
The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels.
"Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 15, 2019 Category: Health Management Authors: John George Source Type: news
FDA approves Wayne company's dissection repair device
The Food and Drug Administration granted marketing approval to Intact's Vascular's Tack Endovascular System on Monday.
The Tack Endovascular System is a dissection repair device implanted in angioplasty patients with peripheral arterial disease. Dissections occur when the inflation of an angioplasty balloon, and the resulting mechanical stress, injures vessels.
"Post-angioplasty dissections can significantly imp act patient outcomes," said Dr. William Gray, the president of the Lankenau Heart Institute… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 15, 2019 Category: Biotechnology Authors: John George Source Type: news
FDA approves Intact Vascular ’ s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.
The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.
The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news