Pulnovo Medical: a Pulmonary Arterial Hypertension medical device company completed the world's first pulmonary hypertension treatment device RCT study after achieving FDA Breakthrough designation. - PRNewswire
- Pulnovo Medical: a Pulmonary Arterial Hypertension medical device company completed the world's first pulmonary hypertension treatment device RCT study after achieving FDA Breakthrough designation. - PRNewswire
- Pulmonary Arterial Hypertension and Post-Capillary Pulmonary Hypertension Related to Left Heart Disease - Healio
- New IPAH Gene Variants Identified in Large Global Study - Pulmonary Hypertension News
- Pulmonary Arterial Hypertension: Diagnosis, Treatment, and Management - Consultant360
| Posted: 28 Jun 2021 05:45 AM PDT NANJING, China, June 28, 2021 /PRNewswire/ -- Recently, Pulnovo Medical's PADN-CFDA clinical trial, the world's first pulmonary hypertension treatment device RCT study, has completed all patients enrollment, and will continue to assist each enrollment center to complete the follow-up of enrolled patients, data recovery, data cleaning, etc., and cooperate with the nation's research center to complete follow-up work. According to reports, the PADN device is aimed at pulmonary hypertension and can be used in conjunction with percutaneous pulmonary artery denervation to treat patients with pulmonary hypertension. Pulmonary hypertension, the occurrence of high blood pressure in the pulmonary arteries, is a disease that is difficult to diagnose and treat. It includes a variety of rare diseases and is called "cancer of the heart and lung vascular system." Without treatment, the average life span of patients is only 2.8 years. Pulmonary hypertension is a "carcinoma in cardiovascular disease" with a very high incidence and fatality rate. The number of patients worldwide is close to 100 million, but until now, pulmonary hypertension is still one of the lesser-known malignant diseases. Previously, the existing treatments for patients with pulmonary hypertension mainly relied on targeted drugs and lung transplantation. According to statistics from the US-Canada team in the article Pulmonary hypertension: the unaddressed global health burden published in Lancet Respiratory Medicine in 2018, the cost of drug treatment for patients with pulmonary hypertension is approximately US$80,000 per year. For most patients, this is an impossible expense to bear. As for lung transplantation, due to the limited source of organs and the common complications of infection and rejection in postoperative patients, lung transplantation is extremely difficult, and it is necessary to take anti-rejection drugs for a long time after surgery. In addition, the high cost of surgery also discourages patients. Pulnovo Medical has brought a new treatment method to patients with pulmonary hypertension. The self-developed radiofrequency ablation product achieved the US FDA Breakthrough designation in 2021. The research results of "Pulmonary Artery Denervation: The New Kid on the Block?" published in the Editorial Comment of JACC Vol. 76, No. 8, 2020 shows that PADN has a better surgical effect and a lower price than drug treatment. Percutaneous pulmonary artery denervation is an interventional ablation technique that punctures the patient's femoral vein and sends a special looped catheter to the proximal end of the pulmonary artery bifurcation. After connecting with a radiofrequency ablation instrument, it damages the serous membrane through the intima of the pulmonary artery. The sympathetic nerve under the layer, when the sympathetic nerve of the proximal pulmonary artery is ablated, the pulmonary artery pressure drops. The clinical data showed that: percutaneous pulmonary artery denervation significantly improved the 6-minute step of polytype pulmonary hypertension, and the mean pulmonary artery pressure and pulmonary vascular resistance were significantly reduced without related complications. In addition, percutaneous pulmonary artery denervation also has a therapeutic effect on mixed pre- and post-capillary pulmonary hypertension secondary to left heart failure. SOURCE Pulnovo Medical   | |||||||||||||||||||||
| Posted: 17 Jun 2021 12:00 AM PDT Pulmonary Arterial Hypertension and Post-Capillary Pulmonary Hypertension Related to Left Heart Disease Activity Overview Target Audience Learning Objectives
Criteria for Success
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| New IPAH Gene Variants Identified in Large Global Study - Pulmonary Hypertension News Posted: 28 Jun 2021 07:11 AM PDT  A study of rare gene variants has identified two new candidates — fibulin 2 (FBLN2) and platelet-derived growth factor D (PDGFD) — that increase risk for adult-onset idiopathic pulmonary arterial hypertension (IPAH). In-depth genetic analyses also predicted that about 15% of IPAH cases in children are caused by de novo variants, which means they are not inherited from the parents. The study, "Rare variant analysis of 4241 pulmonary arterial hypertension cases from an international consortium implicates FBLN2, PDGFD, and rare de novo variants in PAH," was published in Genome Medicine. PAH usually arises in people with no known family history of the condition. Mutations in a gene linked to PAH, called BMPR2, have been found in up to 20% of cases previously classified as idiopathic, meaning with no identified cause, but disease-causing mutations remain unidentified in a relevant percentage of patients. When PAH is inherited, also known as familial (FPAH), it typically follows an autosomal dominant pattern of inheritance where one copy of an altered gene is enough to cause disease. However, many people with one copy never develop the condition. This suggests the presence of other contributing factors that may be genetic and/or environmental. Previous studies have indicated that rare genetic mutations are estimated to be the cause of about 75%–80% of FPAH, at least 10% of adult-onset IPAH, and up to about 36% of pediatric-onset IPAH. As such, many non-familial PAH cases remain genetically undefined. To address this knowledge gap, researchers in the U.S. and U.K. set out to determine risk variants for several genetic subtypes of PAH. The analysis was carried out in a total of 4,241 PAH cases from the National Biological Sample and Data Repository for PAH, U.K. NIHR BioResource — Rare Diseases Study, and Columbia University Irving Medical Center. The analysis of de novo variants included a subset of 124 trios of affected children but unaffected parents. The combined U.S./U.K. group included 54.6% IPAH, 34.8% APAH, 5.9% FPAH, and 4.6% other types of pulmonary arterial hypertension. APAH refers to PAH associated with connective tissue diseases, congenital heart disease, and others. Most of the cases were adult-onset (92.6%) and the mean age at diagnosis was 45.9 years. The majority of patients were female (75.1%) and European (74.5%). Other ethnicities included African (8.7%), Hispanic (8.6%), South Asian (2.8%), and East Asian (2.5%). Among pediatric-onset cases, the female-to-male ratio was significantly lower compared to the adult-onset cases. Rare variants in the gene BMPR2 that increase PAH risk were identified in 7.7% of overall cases (9% of IPAH, 56.6% of FPAH, and 0.88% of APAH). Previous studies have identified more than 600 BMPR2 gene variants that cause FPAH. When limiting their search to European cases, the researchers found rare predicted variants in seven genes — BMPR2, GDF2, TBX4, SOX17, KDR, FBLN2, and PDGFD — that were significantly associated with IPAH. FBLN2 and PDGFD have known functions in blood vessel formation and remodeling. Both genes showed missense variants, which means a change in the genetic sequence that leads to the production of a different amino acid — the building blocks of proteins. Next, the entire combined group was screened, including patients of non-European ancestry, for rare missense variants in FBLN2 and PDGFD. Seven cases were found to carry FBLN2 mutations (six IPAH and one APAH) and 10 cases carried PDGFD variants — nine IPAH and one PAH. Most of the carriers were of European ancestry. FBLN2 mutation carriers had increased mean pulmonary capillary wedge pressure, a measure of pressure on the left side of heart, compared to the overall group. All the FBLN2 and PDGFD variant carriers were diagnosed with PAH class II or III, and five out of seven FBLN2 carriers had systemic (body-wide) hypertension. The team then analyzed the subset of 124 child-parent trios and found that it consisted of 55.6% IPAH cases and 37.9% APAH-congenital heart disease cases. Seven of the variants were found in known PAH risk genes: four in TBX4, two in BMPR2, and one in ACVRL1. Among the IPAH cases, the variants were missense or classified as likely gene-disrupting and missense. In addition, the trio analysis predicted that about 15% of pediatric IPAH could be explained by de novo variants. The rare de novo variants carried by PAH cases in children were linked to genes implicated in several developmental syndromes, such as Noonan syndrome. In the patients who carried likely gene-disrupting or missense de novo variants, the team found a higher ratio of girls vs. boys with a mean age of onset of 5.4 years. The researchers found that 50% of the cases had IPAH, 33.3% APAH-congenital heart disease, and an overlap of 36.1% of cases had other congenital or growth and development conditions. "We have identified FBLN2 and PDGFD as new candidate risk genes for adult-onset IPAH," the scientists wrote. "We estimate that [approximately] 15% of all pediatric cases are attributable to de novo variants and that many of these genes are likely to have important roles in developmental processes. Larger adult and pediatric [groups] are needed to better clinically characterize these rare genetic subtypes of PAH."  | |||||||||||||||||||||
| Pulmonary Arterial Hypertension: Diagnosis, Treatment, and Management - Consultant360 Posted: 04 Jun 2021 12:00 AM PDT [unable to retrieve full-text content]Pulmonary Arterial Hypertension: Diagnosis, Treatment, and Management Consultant360  | |||||||||||||||||||||
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