LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae. The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Optiflow Arterial cannulae have a “basket tip with large openings,” LivaNova reported, which has been shown to significantly reduce wall shear stress and turbulence. This feature could help lessen ischemic complications from extracorporeal circulation during cardiac surgery, the compan...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat LivaNova Source Type: news
Transcatheter heart valve surgery simulator dev FEops raises $7m
Surgical simulation software developer FEops said today it raised $7.2 million (EU €6 million) in funding to support its HeartGuide transcatheter valve implantation simulation software. The round was led by newly invested Valiance and joined by existing investors Capricorn and PMV, the Gent, Belgium-based company said. FEops’ flagship product is the HeartGuide platform, which use advanced computer simulations to provide both clinicians and valve manufacturers with insights into the interaction between valves and patient anatomy preoperatively to improve clinical outcomes, the company claims. “The shift tow...
Source: Mass Device - September 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Software / IT Surgical feops 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 ...
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
Investors seek class action status in lawsuit over St. Jude implantable defib batteries
Abbott (NYSE:ABT) is facing an investor suit from an Alaskan union-benefits fund over allegations that St. Jude Medical, which it closed its acquisition of in January, failed to notify regulators about defective lithium batteries in its implantable defibrillators. In the lawsuit, plaintiffs allege that St. Jude was informed of the battery defect “as early as 2011”, but it failed to take action and would wait 5 years before issuing a recall for the devices. St. Jude received 42 product reports which showed “evidence of premature battery depletion due to lithium cluster bridging,” court documents...
Source: Mass Device - September 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Legal News Abbott stjudemedical Source Type: news
Carotid Interventions Dropping for Seniors
(MedPage Today) -- Both stenting and surgery declined since 2007 but outcomes improved (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 19, 2017 Category: Cardiology Source Type: news
Mesothelioma Clinical Trials Involve Gene Therapy
Treatment options for malignant mesothelioma may soon include customized gene therapy, according to thoracic surgeon and scientist Dr. Prasad Adusumilli at Memorial Sloan Kettering Cancer Center in New York. Gene therapy involves a laboratory reprogramming of a patient’s own T cells, which are a type of white blood cell, to recognize and destroy the cancer. The U.S. Food and Drug Administration (FDA) recently approved the first gene therapy specifically for pediatric leukemia, signaling the start of a new approach to cancer treatment in this country. The newly approved treatment is also known as chimeric antigen rece...
Source: Asbestos and Mesothelioma News - September 19, 2017 Category: Environmental Health Authors: Matt Mauney Tags: CAR T cell therapy checkpoint blockade chimeric antigen receptor T cell therapy Dr. Andy Haas Dr. Prasad Adusumilli Dr. Scott Gottlieb FDA Commissioner gene therapy cancer gene therapy for mesothelioma immunotherapy clinical trial mali Source Type: news
Pearls from: Samar Hafida, MD
(MedPage Today) -- Metabolic surgery is a viable treatment option for type 2 diabetes (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 19, 2017 Category: Cardiology Source Type: news
HRS releases CIED lead extraction guidelines
The Heart Rhythm Society this week released its guidelines on device lead management and extraction for implantable cardiovascular electronic devices. The new guidelines are the result of a collaboration amongst 10 international organizations, according to the HRS. Included contributing organizations are the HRS, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, American Society of Anesthesiologists, European Heart Rhythm Association, Infectious Diseases Society of America, Latin American Hearth Rhythm Society, Pediatric and Congenital Electrophysiology Society and the Society o...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Heart Rhythm Society Source Type: news
VIDEO: Magovern honored with Health Care Heroes career achievement award (Video)
Dr. George Magovern Jr. received a career achievement award during the Health Care Heroes Awards ceremony, which was held Thursday night at the Omni William Penn Hotel downtown. Magovern is one of the country's most renowned cardiac surgeons. He is chairman of the Department of Thoracic and Cardiovascular Surgery for Allegheny Health Network. The Pittsburgh Business Times' 2017 Health Care Heroes Career Achievement Award honored his commitment to quality health care in th e region and a career filled… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 15, 2017 Category: American Health Authors: Richard Cerilli Source Type: news
LivaNova heater-cooler implicated in infections in 12 pediatric heart surgery patients
A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report. A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients with infections identified through phone calls to families. A number of patients who have only received phone calls are slated to see doctors this week, leaving the possibility that the numbers will grow, STAT reports. The hospital has since replaced the contaminated ...
Source: Mass Device - September 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Surgical LivaNova Source Type: news
AtriCure launches AtriClip Pro-V in the US
AtriCure (NSDQ:ATRC) said today it launched its AtriClip Pro-V left atrial appendate exclusion system in the US. The newly launched AtriClip Pro-V is designed to be placed through a minimally-invasive surgery and features an open-ended design and tip-first closure mechanism for easier navigation, the Mason, Ohio.-based company claims. “Development of the AtriClip Pro-V is another step in the direction of a comprehensive strategy for management of the left atrial appendage. It expands the options for minimally invasive approaches including right chest access and an easier implantation of an epicardial atrial appe...
Source: Mass Device - September 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves AtriCure Inc. Source Type: news
Even Mild Secondary Mitral Regurgitation Tied to Reduced Survival
(MedPage Today) -- Unclear if surgery, transcatheter procedures are better than medical therapy for valve disease (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 8, 2017 Category: Cardiology Source Type: news
7 medtech stories we missed this week: Sept. 8, 2017
[Image from unsplash.com]From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating a pediatric capability for its BrainScope One medical neurotechnology. The technology is an FDA-cleared handheld medical device that is designed to assess the full spectrum of traumatic brain injury. The company sa...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiac Assist Devices Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Imaging mHealth (Mobile Health) Neurological Regulatory/Compliance Research & Development Spinal AliveCor Bonesupport Bra Source Type: news
Villafa ña-founded artificial vessel developer Medical 21 looks to raise $15m
St. Jude Medical founder Manny Villafaña’s newest medtech play, Medical 21, is looking to raise $15 million in an equity round of funding, according to an SEC filing posted recently. The company is developing an artificial blood vessel as an alternative to harvesting blood vessels for coronary artery bypass surgeries, and has already begun animal testing of the technology, according to a Twin Cities Business report. Bypass surgeries, which are performed over 500,000 times a year in the US, require surgeons to harvest blood vessels from a patient’s body to be stitched into the heart to repair the circulat...
Source: Mass Device - September 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular medical21 Source Type: news
Traditional Chinese medicine - How to heal the body naturally
(Natural News) Over the past few decades, the incidence of many chronic degenerative diseases including cancer, autoimmune disorders, diabetes, cardiovascular problems and Alzheimer’s disease have all risen by an alarming rate – and Western medicine offers no cure. And, while conventional medicine continues to ‘treat’ every ill with a pill or surgery – the actual... (Source: NaturalNews.com)
Source: NaturalNews.com - September 6, 2017 Category: Consumer Health News Source Type: news
Mesothelioma Patients Survive Longer with Trimodal Treatment
Pleural mesothelioma patients who undergo aggressive multimodal treatment live almost twice as long after diagnosis than those who do not, according to a recent extensive study. Researchers at MD Anderson Cancer Center in Texas found a combination of surgery, chemotherapy and radiation extended survival time significantly, regardless of disease histology or cancer stage. “We recommend that all patients with [malignant pleural mesothelioma] be evaluated by multidisciplinary teams that are experienced in the management of mesothelioma for consideration of surgery-based, multimodality treatment,” the authors wrote...
Source: Asbestos and Mesothelioma News - September 5, 2017 Category: Environmental Health Authors: Matt Mauney Tags: biphasic histology Dr. Anne Tsao Dr. Boris Sepesi Dr. Daniel Gomez Dr. David Rice Dr. Mark Berry epithelial mesothelioma Journal of Clinical Oncology md anderson cancer center mesothelioma chemotherapy mesothelioma mortality surgery Source Type: news
GPs underestimate impact of migraine on patients
Poor workplace support for migraine sufferers Related items fromOnMedica New radiology treatment can tackle migraine pain Migraines linked to cardiovascular disease and death in women Combined oral contraception, migraine and stroke Migraine could raise risk of stroke after surgery (Source: OnMedica Latest News)
Source: OnMedica Latest News - September 5, 2017 Category: UK Health Source Type: news
One in 10 men aged 50 'have the heart of a 60-year-old'
"One-tenth of 50-year-old men have a heart age 10 years older than they are," BBC News reports. This is the finding of an analysis of 1.2 million people who used the NHS Heart Age Test. The principle behind the test is that you can "age" your heart through unhealthy behaviour such as smoking and being obese. Underlying conditions like high blood pressure and high cholesterol, which often have no noticeable symptoms, can also age the heart. An obese smoker in their 50s who has high blood pressure and high cholesterol could have the heart of a 60- or 70-year-old. The quick and simple test tells you the...
Source: NHS News Feed - September 4, 2017 Category: Consumer Health News Tags: Heart/lungs Source Type: news
Nigeria: 900 African Heart Surgeons in Nigeria for Confab
[Vanguard] Enugu -No fewer than 900 heart surgeons will this month storm Nigeria for a congress of the African Association of Thoracic and Cardiovascular Surgeons, AATCVS. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - September 4, 2017 Category: African Health Source Type: news
Dextera Surgical wins expanded FDA nod for MicroCutter 5/80 stapler
Dextera Surgical (NSDQ:DXTR) said today it won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ parenchymal dissection techniques. The new clearance covers use on organs including the liver, kidney, pancreas and spleen, the Redwood City, Calif.-based company said. “The small size and large degree of articulation provided by the MicroCutter 5/80 is especially beneficial in maneuvering within the confined spaces around solid internal organs. In addition, with the small footprint of the MicroCutter’s jaws, I’m able to successfully op...
Source: Mass Device - August 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Surgical dextera Source Type: news
Philips subsidiary Spectranetics recalls Bridge occlusion balloon
Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was prompted by nine reports of blocked guidewire lumens, although no deaths or serious injuries were reported. “Based on inspection, the frequency of a potentially blocked guidewire lumen is estimated to be approximately 10%,” the company said. “As the Bridge occlusion balloon serves an important role in preventing b...
Source: Mass Device - August 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Catheters Recalls royalphilips Spectranetics Corp. Source Type: news
Abbott launches Amplatzer newborn congenital heart defect trial
Abbott (NYSE:ABT) said today it launched a US pivotal trial looking to explore the safety and effectiveness of a modified version of its Amplatzer device designed to correct patent ductus arteriosus, a congenital heart defect in pre-term infants. “Patent ductus arteriosus is one of the most common heart defects, accounting for 5% to 10% of all congenital heart disease. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed,” principal investigator Dr. Evan Zahn of Los Angeles’ Cedars-Sinai Heart Institute said in a prepared statement. Patent du...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Abbott Source Type: news
A Brighter Future For Babies With Heart Defects
Peter Pastuszko, MD Chief of Pediatric Cardiac Surgery Director of Pediatric Cardiovascular Services Mount Sinai Health System (Source: Healthy Living - The Huffington Post)
Source: Healthy Living - The Huffington Post - August 30, 2017 Category: Consumer Health News Source Type: news
Anti-inflammatory drug may help prevent heart attacks
Conclusion This well-conducted study shows promising signs that canakinumab may reduce the risk of future heart attacks and other cardiovascular events in people who've had them in the past. But before any changes are made to the current licensing of this drug, further research is needed to confirm the beneficial effects and the optimal dose. Most importantly, researchers will need to focus on the observation that the drug lowered white blood cell counts and increased the risk of fatal infection. They estimated around 1 in every 300 people taking canakinumab would die of a fatal infection. This number, while low, is sti...
Source: NHS News Feed - August 30, 2017 Category: Consumer Health News Tags: Heart/lungs Source Type: news
Upcoming Mesothelioma Symposium Filled with Hope
Discussions About Immunotherapy for Mesothelioma Cameron also will speak about engineering mesenchymal stem cells for immunotherapy. Clare Cameron, who is the executive director of the Pacific Mesothelioma Center (PMC) and not related to Dr. Robert Cameron, will talk about resources for research. Lein Hua-Feng, a nurse practitioner at PMC, will discuss the benefits of caregiver support groups. “The symposium will provide an unrivaled opportunity for both the medically savvy and general public, including mesothelioma patients,” Clare Cameron said. “You’ll hear about the most promising medical advance...
Source: Asbestos and Mesothelioma News - August 29, 2017 Category: Environmental Health Authors: Matt Mauney Tags: 7th annual International Symposium on Mesothelioma Angiogenesis Inhibition and Chemotherapy Arti Shukia Banaras Hindu University bap1 Center at the University Hospital of Siena clare cameron Dr. Anna Nowak Dr. Brian Cunniff Dr. David Sch Source Type: news
ESC: Concomitant LAA Closure During Heart Surgery Scores a Win
(MedPage Today) -- But will making it routine safely prevent strokes? (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 28, 2017 Category: Cardiology Source Type: news
ESC focused update on dual antiplatelet therapy in coronary artery disease published today
(European Society of Cardiology) The first ESC Focused Update on Dual Antiplatelet Therapy in Coronary Artery Disease is published online today in European Heart Journal,1 and on the ESC website.2 The document was developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - August 26, 2017 Category: International Medicine & Public Health Source Type: news
ESC/EACTS Guidelines for the management of valvular heart disease published today
(European Society of Cardiology) European Society of Cardiology (ESC) / European Association for Cardio-Thoracic Surgery (EACTS) Guidelines for the management of valvular heart disease are published online today in European Heart Journal1 and on the ESC website. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - August 26, 2017 Category: International Medicine & Public Health Source Type: news
Large study reveals women have superior response to esophageal cancer treatment
(Elsevier) Female patients with locally advanced esophageal cancer that is treated with chemotherapy and radiation therapy before surgery are more likely to have a favorable response to the treatment than male patients are, and women are less likely to experience cancer recurrence, according to a study published online today in The Annals of Thoracic Surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 22, 2017 Category: International Medicine & Public Health Source Type: news
BioVentrix wins FDA IDE nod, launches Revivent TC trial
BioVentrix said today it received FDA investigational device exemption approval and launched a safety and efficacy trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients suffering from ischemic cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer surface and along one of the inside walls, according to the San Ramon, Calif.-based company. The San Ramon, Calif.-based company said it enrolled the 1st patient in the Alive trial, wi...
Source: Mass Device - August 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) BioVentrix Source Type: news
Nearly One-Third of Mesothelioma Patients Remain Untreated
A new report from the National Cancer Institute (NCI) shows between 20 and 30 percent of malignant mesothelioma patients do not receive any cancer treatment. The study, “Patterns of care and survival among patients with malignant mesothelioma in the United States,” published August 10 in the journal Lung Cancer, aimed to describe the patterns of care and subsequent survival among mesothelioma patients in the U.S. while adjusting for patient demographics and pre-existing health conditions. Using the NCI’s Surveillance, Epidemiology, and End Results (SEER) data, researchers discovered significant differenc...
Source: Asbestos and Mesothelioma News - August 21, 2017 Category: Environmental Health Authors: Matt Mauney Tags: amount of mesothelioma patients eligible for surgery checkpoint inhibitors clinical trial enrollment cytoreduction surgery heated chemotherapy pleural mesothelioma heated intraperitoneal chemotherapy immunotherapy mesothelioma keytruda Lin Source Type: news
CMS proposes rolling back bundled payment programs
The Centers for Medicare & Medicaid Services this week proposed rolling back a trio of bundled payment pilot programs aimed at lowering healthcare costs and improving outcomes. The federal health insurer announced its 5-year “Comprehensive Care for Joint Replacement” program in July 2015, saying it would involve more than 800 hospitals in 75 geographic areas. The CJR program, which went into effect in January 2016, bundles payments for hip and knee replacements from hospital admission to 90 days after discharge. The payment covers “all related items and services paid under Medicare Part A an...
Source: Mass Device - August 17, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Healthcare Reform Centers for Medicare and Medicaid Services (CMS) Reimbursement valuebasedhealthcare Source Type: news
Abbott ’ s new contact ablation catheter: Here ’ s what you need to know
The new TactiCath contact ablation catheter unites EndoSense and St. Jude Medical technologies that Abbott acquired, marrying fiber optics, flexibility and 3D mapping. [Image courtesy of Abbott]If you want your grilled cheese to cook faster, you press it into the pan with your spatula. That’s contact force, the principle behind Abbott’s TactiCath contact force ablation catheter, according to Srijoy Mahapatra, Abbott’s VP of medical, clinical and scientific affairs. Abbott acquired TactiCath with the purchase of St. Jude Medical this year. (St. Jude acquired Swiss company Endosense in 2013.) The latest ver...
Source: Mass Device - August 14, 2017 Category: Medical Devices Authors: Heather Thompson Tags: Cardiovascular Catheters Abbott Source Type: news
7 medtech stories we missed this week: August 11, 2017
[Image from unsplash.com]From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally m...
Source: Mass Device - August 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Food & Drug Administration (FDA) Oncology Regulatory/Compliance Spinal Surgical Apifix Cardiac Science Hip Innovation Life Spine Inc. MedTech Pentax Medical Varian Medical Systems Xtant M Source Type: news
Marrow Fat Linked to Bone Loss after Bariatric Surgery (CME/CE)
(MedPage Today) -- T2D patients had less marrow fat but better bone density post-RYGB (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 9, 2017 Category: Cardiology Source Type: news
Lung-Sparing P/D Surgery Best for Mesothelioma Patients
The latest studies have shown, and most thoracic oncologists agree, that lung-sparing pleurectomy/decortication is a better surgical option for mesothelioma patients today than the more aggressive extrapleural pneumonectomy. Less is better. Quality of life becomes better, too. “In most instances, the pleurectomy/decortication is the operation of choice now,” thoracic surgeon Dr. Andrea Wolf at Mount Sinai Hospital in New York City, told Asbestos.com. “We’re finding that patients just do better in terms of survival and in terms of quality of life.” Wolf recently co-authored “The impact of...
Source: Asbestos and Mesothelioma News - August 9, 2017 Category: Environmental Health Authors: Matt Mauney Tags: Annals of Translational Medicine best surgery for mesothelioma Dr. Andrea Wolf Dr. Hasan Batirel eligible for mesothelioma surgery extrapleural pneumonectomy lung-sparing surgery Marmara University Hospital mesothelioma histology mesothe Source Type: news
Levosimendan Flops in Cardiac Surgery Trial
(MedPage Today) -- Calcium sensitizer fails to cut incidence of low cardiac output syndrome (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 9, 2017 Category: Cardiology Source Type: news
FDA updates on Getinge/Datascope IABP recall, labels as Class I
The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The recall affects approximately 9,194 units in the US with model numbers CS100i, CSO100 and CS300, including all lot numbers manufactured before June 30, 2013 and distributed...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Food & Drug Administration (FDA) Recalls Datascope Corp. Getinge Maquet Cardiovascular LLC Source Type: news
LivaNova wins CMS NTAP reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless aortic heart valve replacement won approval from the Centers for Medicare and Medicaid Services for a New Technology Add-On Payment. The London-based company said that the Perceval valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies. With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said. “We are pleased ...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) LivaNova Source Type: news
UPDATE: CMS passes NTAP reimbursement for LivaNova ’ s Perceval, Edwards Intuity aortic valves
Updated to include that the CMS NTAP also covered Edwards Lifescience’s Intuity suturless aortic valve The Centers for Medicare and Medicaid Services today released its Final Rule for FY2018 Medicare Inpatient Payment and Policy, granting New Technology Add-On Payment reimbursement for rapid deployment valves, including LivaNova‘s (NSDQ:LIVN) Perceval and Edwards Lifesciences‘s (NYSE:EW) Intuity aortic valves. London-based LivaNova said that the Perceval sutureless valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technol...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Edwards Lifesciences LivaNova Source Type: news
G. Randall Green named chief of cardiac surgery
He will also co-direct the Upstate Heart Institute, a priority in the Upstate strategic plan, that calls for strengthening and expanding cardiovascular services. (Source: SUNY Upstate Medical)
Source: SUNY Upstate Medical - August 4, 2017 Category: Universities & Medical Training Source Type: news
RTI Surgical deals cardiothoracic biz to A & E Medical for $60m
RTI Surgical (NSDQ:RTIX) said today it sold its cardiothoracic closure business to Vance Street Capital portfolio company A&E Advanced Closure systems for $60 million. Through the deal, RTI Surgical will receive an initial $54 million in cash with an additional $6 million in contingent cash consideration for its cardiothoracic closure business, which was part of its Pioneer Surgical Technology acquisition in July 2013 and provides cardiothoracic sternal metal cable and plating systems. As part of the transaction, RTI Surgical said it inked a multi-year contract manufacturing agreement to continue to support the di...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Surgical RTI Surgical Source Type: news
Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and fo...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news
Medtronic wins FDA nod, CE Mark for Avalus aortic valve
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease. The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central regurgitation. The valve also features interior-mounted leaflet and frame design for improved durability and a low-profile design with a streamlined valve holder and single, one-cut release for easier implantations, Medtronic said. “Medt...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Rebound Therapeutics raises $17m in Series B
Minimally invasive surgical device developer Rebound Therapeutics said today it closed a Series B round of financing, raising $16.5 million. The round was led by HBM-MedFocus, Invus Opportunities Fund and Wexford Capital affiliates, the Irvine, Calif.-based company said. Funds from the round are slated to support product develpoment, regulatory approvals, scaling up manufacturing and commercialization efforts. Rebound Threapeutics said it has developed a “unique array of devices to improve the procedural and clinical outcomes” of minimally invasive surgical procedures, and that device testing is scheduled to be...
Source: Mass Device - July 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical reboundtherapeutics Source Type: news
Surgeon Mark McCoy Joins Mercy Clinic (NWA Movers & Shakers)
Dr. Mark McCoy has joined Mercy Clinic Cardiovascular & Thoracic Surgery in Fort Smith as a cardiovascular surgeon. (Source: Arkansas Business - Health Care)
Source: Arkansas Business - Health Care - July 24, 2017 Category: American Health Source Type: news
Less invasive treatment for blocked artery in the leg is safe, review finds
This study shows that the orbital atherectomy treatment can offer patients a safe and effective alternative to surgery.AUTHORSThe authors of the study are Dr. Michael Lee and Dr. Daniel Heikali of UCLA; Dr. Jihad Mustapha of Metro Health Hospital in Wyoming, Mich.; Dr. George Adams of Rex Healthcare in Raleigh, N.C.; and Dr. Ehtisham Mahmud of UC San Diego.JOURNALThis study was published by the peer-reviewed journal Vascular Medicine.FUNDINGThis research was funded Cardiovascular Systems Inc., the makers of the orbital atherectomy device.DISCLOSURESDrs. Lee, Mustapha and Adams received funding from Cardiovas...
Source: UCLA Newsroom: Health Sciences - July 19, 2017 Category: Universities & Medical Training Source Type: news
Imaging Tracks Changes in Gastric Microcirculation During Surgery Imaging Tracks Changes in Gastric Microcirculation During Surgery
Laser speckle contrast imaging (LSCI) during esophagectomy shows that changes in gastric microcirculation have more to do with surgery than thoracic epidural anesthesia (EA) or use of vasopressors, according to Danish researchers.Reuters Health Information (Source: Medscape Radiology Headlines)
Source: Medscape Radiology Headlines - July 13, 2017 Category: Radiology Tags: Radiology News Source Type: news
Medical News Today: Viagra may reduce blood clots after stent surgery
New research suggests stents coated with sildenafil may have a much lower chance of causing blood clotting or artery narrowing than other stents. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - July 11, 2017 Category: Consumer Health News Tags: Cardiovascular / Cardiology Source Type: news