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 “substantial” future clinical and regulatory milestone payments to Orchestra BioMed, plus a “strong commitment” 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 it will “share meaningfully” in future commercial revenues of Virtue SEB through royalities and per unit payments as the exclusive supplier of the sustained-release sirolimus formulation used in Virtue SEB. The company also retains rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions. Unlike other angioplasty balloons involving a drug, Virtue SEB is unique in that it is not a drug-coated balloon, but rather a drug-eluting balloon designed to deliver a bioabsorbable sustained-release formulation of sirolimus, a drug commonly used for preventing restenosis after a percutaneous interventional procedure. In April, FDA granted the device a breakthrough device designation for treatment of coronary in-stent restenosis (ISR). FDAâ€...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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Abstract Benign central venous thoracic occlusion is a frequent issue in haemodialysis patients. Symptomatic stenosis affects quality of life and can cause dysfunction of arteriovenous access or make it impossible to implant a haemodialysis catheter. Common risk factors for the development of the occlusions are central venous catheters and cardiac rhythm devices. The gold standard for diagnosis is venous angiography. Treatment of asymptomatic lesions can lead to clinical deterioration and should be avoided. The primary method of treatment for symptomatic patients is endovascular therapy. Repeat balloon angioplasty...
Source: Zentralblatt fur Chirurgie - Category: Surgery Authors: Tags: Zentralbl Chir Source Type: research
Authors: Liu H, Gu Y, Yang S, He J, Zhang F Abstract The aim of the present retrospective study was to evaluate the feasibility, safety and the primary results following application of excimer laser atherectomy (ELA) combined with adjunctive drug-coated balloon angioplasty (DCBA) as the first-line endovascular treatment for patients with chronic obstructive femoropopliteal arterial disease. The baseline characteristics and angiographic variables of all patients who underwent ELA for stable chronic obstructive femoropopliteal arterial disease at Tianjin First Central Hospital (Tianjin, China) between May and Decembe...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Condition:   Coronary Artery Disease Interventions:   Device: OCT-guided paclitaxel drug-coated balloon angioplasty;   Device: Angiography-guided paclitaxel drug-coated balloon angioplasty Sponsor:   Beijing Anzhen Hospital Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
ConclusionsDrug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12  months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality.Level of EvidenceLevel Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.
Source: CardioVascular and Interventional Radiology - Category: Radiology Source Type: research
AbstractBackgroundThe randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1  year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.MethodsEight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel  
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
This study sought to assess outcomes of different patterns of DES-ISR treated with DCB. From December 2014 to December 2016, a total of 160 DES-ISR lesions treated with DCB were retrospectively evaluated. Restenosis patterns were classified into two groups according to Mehran classification: focal, defined as  
Source: The International Journal of Cardiovascular Imaging - Category: Radiology Source Type: research
ConclusionInterarterial segment stenting appears feasible and safe. More important population and longer follow-up are needed to include this approach in a future management algorithm for patients with ANOCOR.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Authors: Onal Y, Samanci C Abstract BACKGROUND: Hemodynamic depression (HD) is a condition that can be encountered after carotid stenting (CAS) and carotid angioplasty (CAP) due to manipulation of the carotid sinus. The aim of this study was to evaluate whether the carotid bifurcation geometry and angles, or changes in angles, were associated with this HD in patients undergoing CAS and CAP. METHODS: Sixty-two patients with a mean age of 71.1 ± 7.4 years, who underwent CAS and CAP for carotid stenosis were included in the study. HD was defined as periprocedural hypotension (systolic blood pressure
Source: International Angiology - Category: Cardiology Tags: Int Angiol Source Type: research
Conclusions DCB angioplasty for de novo small coronary lesions in the real-world environment in Japan is effective with acceptable 12-month outcomes.
Source: Coronary Artery Disease - Category: Cardiology Tags: Myocardial Infarction/Cardiogenic Shock Source Type: research
Publication date: Available online 3 December 2019Source: Journal of Cardiology CasesAuthor(s): Kazunori Takemura, Masaharu Maegaki, Ryuta Nakamura, Tetsuro Takase, Kaneto Mitsumata, Tomoaki Tanabe, Imun TeiAbstractSpontaneous coronary artery dissection (SCAD) usually occurs in women, which can result in significant morbidities. A 38 year-old obese man who is currently smoking was referred to our hospital with chest pain. His electrocardiography and echocardiography suggested myocardial infarction in proximal region of left coronary artery. Emergent coronary angiography revealed 99% stenosis at mid portion of LAD and diffu...
Source: Journal of Cardiology Cases - Category: Cardiology Source Type: research
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