Pulmonary arterial hypertension device wins FDA breakthrough designation - MedTech Dive
Pulmonary arterial hypertension device wins FDA breakthrough designation - MedTech Dive |
| Pulmonary arterial hypertension device wins FDA breakthrough designation - MedTech Dive Posted: 09 Sep 2019 12:00 AM PDT  Dive Brief:
Dive Insight:PAH, in which obstruction in the small arteries of the lungs increases pressure in the vessels, is a rare condition affecting about 15 to 50 people per million in the United States according to the American Lung Association. The increased blood pressure over time can damage the heart. Patients typically receive medications to treat PAH. SoniVie's device is the first treatment to use high-frequency non-focused ultrasound energy to ablate nerves associated with PAH. The Israeli startup developed the device based on prior technology designed for renal denervation by Cardiosonic. In May, the company appointed Charles Carignan as CEO. Carignan is a former CEO of Rex Bionics, BionX Medical Technologies and NinePoint Medical. He also previously held the post of chief medical officer at Novasys Medical and chief medical officer for endosurgery and minimally invasive therapies at Boston Scientific. The TROPHY1 trial found no serious adverse events related to the device or procedure and showed improvements in pulmonary vascular resistance, mean pulmonary artery pressure, six-minute walk distance, daily activity and European Society of Cardiology (ESC) low-risk indicators compared with baseline assessments. The company has launched a clinical trial of the TIVUS device in Group 2 pulmonary hypertension patients and expects to begin a pivotal trial of the system in 2020. In addition to gaining assistance from FDA that can accelerate the development and approval process, companies that receive the agency's breakthrough device designation now may also benefit from an alternative reimbursement system. In August, CMS finalized an alternative technology add-on pathway for breakthrough devices under its Inpatient Prospective Payment System for fiscal 2020. Medtronic is also targeting the PAH market. The device maker last year won FDA approval for an implantable system that delivers the drug Remodulin (treprostinil) developed by United Therapeutics.  |
| Posted: 26 Sep 2019 11:04 PM PDT 
 Pulmonary Arterial Hypertension Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2019-2025- Changing consumer lifestyle and growing consumption of alcohol and tobacco drive the market growth. Global Pulmonary Arterial Hypertension Market is valued at USD 5.85 Billion in 2018 and expected to reach USD 10.36 Billion by 2025 with a CAGR of 8.5% over the forecast period. Pulmonary arterial hypertension referred to the high blood pressure in the arteries going to the lung. In healthy individuals, the blood pressure in these arteries is much lower than in the rest of the body and the blood pressure of the arteries going to the rest of the body is around 120/80 millimeters of mercury (mm Hg) and pulmonary artery blood pressure is about 25/10 mm Hg. If the pulmonary arterial pressure exceeds about 40/20 mm Hg or the average pressure exceeds 25 mm Hg, then it is called pulmonary arterial hypertension. The right ventricle of the heart, which supplies blood to the pulmonary arteries, is unable to pump effectively If pulmonary hypertension persists or becomes very high. In this situation, the person experiences symptoms such as; loss of energy, shortness of breath and edema, which is a sign of right heart failure. The major cause of pulmonary hypertension is schistosomiasis. The other major risk factor for pulmonary hypertension is high altitude. It is estimated that more than 140 million persons worldwide and up to 1 million in the United States live 10,000 feet or more above sea level. It is more common among women, non-Hispanic blacks, and among people aged 75 or older. Heart failure is common in pulmonary hypertension. Get Sample Copy of This Premium Report @ https://brandessenceresearch.biz/Request/Sample?ResearchPostId=140126&RequestType=Sample Global pulmonary arterial hypertension market report is segmented on the basis of drug class and region & country level. Based upon drug class, global pulmonary arterial hypertension market is classified into prostacyclin and prostacyclin analogs, soluble guanylate cyclase stimulators, endothelin receptor antagonists (ERAs) and phosphodiesterase-5 (PDE-5) inhibitors. The regions covered in this Pulmonary Arterial Hypertension Market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, the market of Pulmonary Arterial Hypertension is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, Middle East Asia (UAE, Saudi Arabia, Egypt) GCC, Africa, etc. Key Players for Global Pulmonary Arterial Hypertension Market Report– Some major key players for Global Pulmonary Arterial Hypertension Market are Novartis International AG, Gilead Sciences, Inc., Liquidia Technologies, Inc., Actelion Pharmaceuticals, Ltd., Pfizer Inc., Dong-A ST Co., Ltd., Merck Sharp & Dohme Corp, Reata Pharmaceuticals, Inc., Bayer HealthCare, Toray Industries, Inc., United Therapeutics Corporation, GlaxoSmithKline Plc. (GSK), Arena Pharmaceuticals and others. News- Drug Identified that could Reverse Pulmonary Arterial Hypertension. August 8th, 2018; Scientists at Stanley Manne Children's Research Institute at Ann & Robert H. Lurie Children's Hospital of Chicago took a major step toward developing a new treatment for pulmonary arterial hypertension (PAH), a severe lung disease with a five-year survival rate of 50 percent. They identified a drug with a positive safety profile that inhibits a gene called HIF-2α, which they discovered earlier promotes the progressive thickening of the lung artery walls—a key feature of PAH called "vascular remodeling," which leads to right-sided heart failure, the main cause of death in PAH patients. Recently, they demonstrated in three clinically-relevant animal models that inhibiting HIF-2α with a compound results in reversal of established PAH, suppression of vascular remodeling and right heart failure, and increased survival. Request for Methodology @ https://brandessenceresearch.biz/Request/Sample?ResearchPostId=140126&RequestType=Methodology Changing Consumer Lifestyle and Growing Consumption of Alcohol and Tobacco Drive the Market Growth. The major factor driving the growth of global pulmonary arterial hypertension market is increasing aging population coupled with the increasing prevalence of liver disease (cirrhosis), chronic lung diseases like emphysema and others. For example; As per Statista; According to the data, from 2013 to 2015 there were over 58 thousand alcohol-related cirrhosis deaths and over 61 thousand cirrhosis deaths with other causes. The death rate for alcohol-related cirrhosis was around 5.4 and for all other cirrhosis it was 5.5. The death rate among those aged 45-54 years in 2015 was 13.9 per 100,000. Some other common underlying causes include pulmonary arterial hypertension from some types of congenital heart disease, connective tissue disease, coronary artery disease, high blood pressure, blood clots to the lungs, and chronic lung diseases like emphysema. In addition, increasing consumption of alcohol and tobacco is also increase the prevalence of pulmonary arterial hypertension and foster the market growth. Furthermore, increasing healthcare spending and favourable government initiatives are also supplementing the market growth. However, lack of awareness may hamper the market growth. In spite of that, increasing approval of new drugs can provide various opportunities for the further growth of the market. North America is Expected to Dominate the Global Pulmonary Arterial Hypertension Market The global pulmonary arterial hypertension market is segmented into North America, Europe, Asia-Pacific Latin America and Middle East & Africa. North America is expected to dominate the global pulmonary arterial hypertension market within the forecast period attributed to the highly developed healthcare infrastructure and increasing cases of pulmonary arterial hypertension in this region. In addition, supportive government initiatives and reimbursement policies and presence of leading players are also supplementing the market growth in this region. Asia Pacific is projected to witness a fast growth at a highest CAGR in the global pulmonary arterial hypertension market owing to high population base, improving healthcare infrastructure in this region. Key Benefits for Global Pulmonary Arterial Hypertension Market Report– Global Pulmonary Arterial Hypertension Market report covers in-depth historical and forecast analysis. Global Pulmonary Arterial Hypertension Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market Opportunities, Competitive Analysis, Regional and Country Level. Global Pulmonary Arterial Hypertension Market report helps to identify opportunities in marketplace. Global Pulmonary Arterial Hypertension Market report covers extensive analysis of emerging trends and competitive landscape. Buy this Report @ https://brandessenceresearch.biz/Buy/Create?ResearchPostId=140126&RequestType=Buy&PurchasePlan=SingleUser Global Pulmonary Arterial Hypertension Market Segmentation: – By Drug Class: By Regional & Country Level: Table of Content 2. Chapter – Global Pulmonary Arterial Hypertension Market Overview: Qualitative Analysis 3. Chapter – Global Pulmonary Arterial Hypertension Market Overview: Quantitative Analysis 4. Chapter – Global Pulmonary Arterial Hypertension Market Analysis: By Drug Class 5. Chapter – Global Pulmonary Arterial Hypertension Market Analysis: By Manufacturer 8. Chapter –Pulmonary Arterial Hypertension Market: Regional Analysis 9. Chapter – Company Profiles About us: Brandessence Market Research and Consulting Pvt. ltd. Brandessence market research publishes market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students. We have a delivery center in Pune, India and our sales office is in London. Contact us at: +44-2038074155 or mail us at alan@brandessenceresearch.biz Website: https://brandessenceresearch.biz Related Report: Medical Devices Industry Reports 2019 Meniscus Implants Market Global Size, Trends, Competitive, Historical & Forecast Analysis, 2019-2025  |
| You are subscribed to email updates from "pulmonary artery hypertension" - Google News. To stop receiving these emails, you may unsubscribe now. | Email delivery powered by Google |
| Google, 1600 Amphitheatre Parkway, Mountain View, CA 94043, United States | |
Comments
Post a Comment