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Industry

Reports about industry: product launches, accreditations, etc.

HyperMed Imaging gains CE Mark for HyperView device

HyperMed Imaging has received approval to apply the CE Mark for the HyperView medical imaging system allowing distribution of the product in Europe. HyperView is also currently distributed in the US. According to the company, HyperView System is a fast, handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient. 

Smith& Nephew launch PICO 7 sNPWT in Europe

Smith & Nephew has launched the PICO 7 Single Use Negative Pressure Wound Therapy System (sNPWT) in Europe, the devices delivers a number of enhancements which benefit both the clinical effectiveness and patient experience. Clinically, the company claims PICO 7 delivers a more efficient vacuum and superior leak management(1), designed to support improved application on anatomically challenging areas where it is traditionally more difficult to achieve and maintain a seal.

LimFlow completes enrolment In US Study assessing pDVA System

LimFlow has completed enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System. The company also announced that the FDA has accepted the company’s proposal to expand the feasibility study by an additional 15 patients and three new sites, bringing the total number of patients enrolled in the feasibility study to 25 US subjects and six US institutions.

Medtronic launches IDE Study to evaluate Abre Venous Stent

Medtronic has initiated its investigational device exemption (IDE) study for the Abre venous self-expanding stent system. The ABRE IDE Study will evaluate the safety and effectiveness of the Abre stent in subjects with iliofemoral venous outflow obstruction. The first procedure, performed in December 2017, by Dr Erin Murphy, director of the venous and lymphatic program at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, NC, and national principal investigator for the ABRE IDE Study in the US.

BD completes CR Bard acquisition for US$24 billion

Becton, Dickinson and Company (BD) has completed the acquisition of CR Bard, a transaction that was first announced in April 2017, for US$24 billion. The combined company, which will have approximately $16 billion in revenue, integrates Bard's 16,000 employees with BD's 65,000 employees. With completion of the acquisition, Bard became a wholly owned subsidiary of BD.

FDA approves 10mg dosing for Xarelto for VTE treatment

Janssen Pharmaceuticals has announced that the FDA approved the 10mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. This approval follows a FDA Priority Review and is based on data from EINSTEIN CHOICE, the only clinical study to find that a Factor Xa inhibitor, specifically Xarelto, demonstrated superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin.

European authorities approve BD acquisition of Bard

BD (Becton, Dickinson and Company) proposed US$24 billion acquisition of CR Bard has been approved by the European Commission, contingent on BD divesting its soft tissue core needle biopsy product line. The agreement has been unanimously approved by the Boards of Directors of both companies. The combination will create a highly differentiated medical technology company ‘uniquely’ positioned to improve both the process of care and the treatment of disease for patients and healthcare providers, the companies announced. 

EU approval for TVA Medical’s EverlinQ 4 EndoAVF System

TVA Medical has announced that its everlinQ 4 endovascular arteriovenous fistula (endoAVF) system has received CE Mark approval in the European Union. The technology uses a 4F catheter system with visual indicators to create hemodialysis access using an endovascular technique without open surgery in the treatment of patients with end-stage renal disease.

ManaMed launches PlasmaFlow digital DVT prevention device

ManaMed has launched the company's first FDA-approved portable and tubeless DVT prevention device is now available to medical practitioners and patients throughout the US. Tubeless and portable, PlasmaFlow is intended for use at home or at the hospital to help prevent the onset of DVT in patients by stimulating blood flow in the extremities.

Medtronic introduces Concerto 3D detachable coil system

Medtronic has announced the launch of its Concerto three-dimensional (3D) detachable coil system intended to be used for embolizations in the peripheral arteries and veins, at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe in Copenhagen, Denmark. The product is now available in both the US and Europe.

VENITI and Boston agree Vici Venous Stent distribution agreement

VENITI have announced that Boston Scientific will distribute the Vici Venous Stent under a limited global distribution agreement. The terms of the agreement and specific regions and countries involved were not disclosed.

Cardinal Health acquires Medtronic's DVT business

Cardinal Health has completed the acquisition of Medtronic's Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency business for US$6.1 billion. The Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency business encompasses 23 product categories across multiple market sites of care, including numerous industry-leading brands, such as Curity, Kendall, Dover, Argyle and Kangaroo.

FDA approves Bevyxxa for VTE in acutely ill patients

The FDA has approved Bevyxxa (betrixaban, Portola Pharmaceuticals), the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

canagliflozin gets FDA warning due to amputation risk

The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, according to the FDA.  The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labelling include the most serious and prominent boxed warning.

The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo.

Acelity launches Prevena Duo Incision Management System

Acelity has announced that its Prevena Duo Incision Management System is now available to physicians in the US. The Prevena Duo System is the first single use negative pressure wound therapy (NPWT) system designed specifically for the simultaneous management of two closed surgical incisions, configured to help reduce post-operative complications in bilateral procedures, such as vascular harvesting.

Acelity announces enhancements to VAC Ulta Therapy System

Acelity has announced that two significant enhancements to the VAC Ulta Therapy System are now available in the US. The VAC Ulta Therapy System, Acelity’s latest generation negative pressure wound therapy (NPWT) system, is now enhanced to improve clinicians’ experiences by leveraging first-to-market connectivity technology. iOn Results Remote Therapy Monitoring (RTM) connects hospitals to Acelity’s unique service and support offering to promote compliance and drive proper patient utilisation of therapy.

Acelity launches VAC Veraflo Cleanse Choice Dressing

Acelity has announced the global launch of the VAC Veraflo Cleanse Choice Dressing, providing clinicians with a novel, adjunctive non-surgical option that may help clean large complex wounds when complete surgical debridement is not possible or appropriate, according to the company. When used with VAC Veraflo Therapy, Acelity’s negative pressure wound therapy and instillation (NPWTi-d) system, the dressing may provide rapid cleansing of wounds with the goal of augmenting the healing environment.

ConvaTec launches Foam Lite ConvaTec Dressing

ConvaTec has announced the US launch of Foam Lite ConvaTec dressing, a light, flexible silicone foam dressing for managing low to non-exuding chronic and acute wounds. The launch of Foam Lite ConvaTec dressing continues the company’s expansion into large, growing segments of advanced wound care, beginning with the successful launch of Aquacel Foam dressing into the $1.2 billion foam market and most recently with the European launch of the Avelle negative pressure wound therapy (NPWT) system into the fast-growing disposable segment of the NPWT market. 

FDA approves Izun Pharmaceuticals’ of Curasite Wound Care Hydrogel

Izun Pharmaceuticals has announced that the FDA has approved the company’s 510(k) application for Curasite Wound Care Hydrogel. Curasite is a proprietary topical combination of three botanical extracts: Centella asiatica, Echinacea purpurea and Sambucus nigra in a hydrogel base. The prescription indications approved for use include the treatment of:

First patient treated with the ClotTriever Thrombectomy System

Inari Medical has announced the first patient has been treated with its ClotTriever Thrombectomy System, a non-surgical devices that removes thrombus from the peripheral vasculature. The ClotTriever system is designed to remove large clot volume from large veins via access sites as small as 6mm. The ClotTriever does not require use of thrombolytic drugs, which carry significant risk of bleeding and are contraindicated in many patients, the company said.

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