Rakuten Medical acquires Medlight

Rakuten Medical today said it has acquired Medlight for an undisclosed amount.

Medlight currently produces and commercializes a large range of catheters and diffusers for optical light delivery. The acquisition will allow Rakuten Medical to utilize Medlight resources and its network of well-qualified subcontractors to facilitate rapid development of new optical devices.

“Medlight is an ideal acquisition, as they are global leaders in the development of light dosimetry technologies for a variety of diseases,” Rakuten Medical CEO Hiroshi Mikitani said in a news release. “This acquisition secures our supply chain, ensuring the needs of patients are met by optimizing and managing continuous improvement of our delivery system.”

Prior to the acquisition, Medlight was the contract manufacturer of Rakuten Medical’s device finishing facility in Germany. It was also a labeler for clinical trial materials and provided QA oversight for …

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How the resumption of elective surgery may spur demand for high-volume surgical instruments

(Image courtesy of Micro)

Hospitals’ need for single-use surgical instruments may spike as they resume elective procedures following the worst of COVID-19. Outsourcing with a credible tubing partner allows OEMs to focus on core competencies internally and free up other resources for maximum competitive advantage.

Jim Jock, Micro

As elective surgeries resume during this time of COVID-19, hospitals will be gearing up to stock their shelves with medical instruments to help meet the demand. Single-use surgical devices such as scissors, graspers, forceps, and dissectors will be in high demand due to their inherent benefit of reducing spread of infection.

One of the most critical components of these instruments is the shaft, which must meet strict diameter requirements while housing critical-to-function subassemblies. Most often, these shafts are made from stainless steel tubing, which may be manufactured from drawn tubing or using an innovative stamped-…

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Cerus Endovascular wins CE mark for microcatheter

Cerus Endovascular today said it received CE mark approval for its CerusEndo MC 021 microcatheter.

The microcatheter is designed to allow physicians to access torturous neurovasculature and deliver therapeutic device to intended targets.

“We remain committed to meeting the ever-increasing needs of the interventional neuroradiologist community, and with that in mind, our team has clearly identified a range of increased performance demands required of a go-to intracranial access microcatheter,” president Stephen Griffin said in a news release. “As a result, we have expanded our key 021 platform so that it can deliver a wider range of devices than it was originally designed for including stents, braided flow diverters and stentrievers, for treatment of both hemorrhagic and ischemic strokes. In particular, the 021 ensures predictable stability and control when delivering larger and braided devices through the device lumen.”

Microcathe…

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AngioDynamics lands 510(k) for ‘smart’ implantable port

AngioDynamics (NSDQ:ANGO) announced that it received FDA 510(k) clearance and CE Mark approval for its SmartPort+ implantable port product.

SmartPort+ is an implantable, subcutaneous port for those who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids, according to a news release.

Get the full story at our sister site, MassDevice.

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Tegra Medical announces major expansions in Massachusetts and Mississippi

Manufacturing director Brian Rua and director of Quick Wire & Tubing, Patty Rushia, at Tegra Medical’s new building in Franklin, Mass.

Tegra Medical announced today that it has purchased an additional building across the street from its Franklin, Mass., headquarters and will expand its space in Hernando, Miss. Together, these moves will increase the company’s worldwide square footage by more than 53% to 356,000 ft2.

The new building in Franklin, Mass., has 120,000 ft2 of manufacturing space and requires minimal renovation, shortening the timeline for occupancy. The company’s Quick Wire and Tubing business, which provides in-stock and custom-finished metal wire and hypotubing, will gain its own dedicated space as it becomes the building’s first occupant later in 2020.

Get the full story on our sister site, Medical Design & Outsourcing.

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What is coextrusion?

Coextruded tubing [Image from Putnam Plastics]Coextrusion is the process of pressing two or more materials into a single piece of tubing.

Coextruded tubing is commonly used in the packaging and medical device industries. For example, multi-layered extruded tubing can be used for drug delivery applications, including insulin delivery, angiography and pain therapy.

Coextruded tubing can also be made into a catheter or to form dual layer tubing. Each tube can be covered with different coatings, such as lubricious or hydrophilic, depending on the application.

The properties of coextruded tubing help produce a laminar structure that allows each layer to contribute a key property to the performance of the tubing, according to a 2017 study in the Fluoropolymers Applications in the Chemical Processing Industries journal. Separate extruders are typically required for the distinct material in coextrusion tubing.

Materials typically associated with coextrusi…

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SMT receives France national reimbursement for heart stent

Sahajanand Medical Technologies recently received full reimbursement confirmation in France for its Supraflex Cruz heart stent.

The Ministry of Health and Public Affairs of France conducted a scientific review for reimbursement. The clinical data the heart stent was evaluated for safety and applicability to France’s population. Reimbursement approval is based on positive clinical data from a trial of patients with ischemic coronary artery disease.

“We have been honored and happy to be the first center to implant the new ultrathin (60 microns) Supraflex Cruz coronary stent in France recently. The initial experience with Cruz has been good with 100% procedure success. We have tested it in 20 patients, some were complex tortuous lesions and we found the product at par with others with excellent deliverability,” Marc Silvestri, an interventional cardiologist in Aix en Provence, France, said in a news release.

Supraflex Cruz features low str…

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Revamp Medical acute heart failure catheter wins FDA breakthrough device designation

Revamp Medical this week said its Doraya acute heart failure catheter received FDA breakthrough device designation.

Doraya is a temporary intravenous catheter that is placed in the inferior vena cava below the renal veins. It applies partial adjustable flow for up to 12 hours.

The device features a flow regulator mechanism that is designed to temporarily reduce central venous pressure and improve the diuretic response in patients with acute heart failure and insufficient response to diuretic therapy.

Revamp Medical is currently evaluating the device and a first in human clinical study in Europe.

“Worsening Renal Function is a major challenge in the treatment of acute heart failure. We hope to provide cardiologists with a valuable tool to improve care of insufficient diuretic responder patients, in hopes of resetting the ‘cardiorenal clock,'”CEO Liu Avitov said in a news release. “As we begin to accelerate our clinical devel…

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VistaMed launches tri-layer, multi-layer tubing

[Image from Freudenberg Medical]Freudenberg Medical today said it is expanding its tri-layer and multi-layer capabilities within its VistaMed business unit.

VistaMed’s tri-layer tubing is made on precision multi-layer extrusion lines in a Class 8 cleanroom. The tubing is designed with a low coefficient of friction and the inner lumen material and material layer allow for easy passage of guidewires through tortuous anatomical pathways.

The inner layer of HDPR material has bond integrity to the outer nylon layer and a tie layer material is used with refined processing techniques. The outer layer material is used for bonding balloons or other tubing.

“Many years of experience in tubing and catheter manufacturing combined with our continuous investment in the latest process technologies ensures that our capabilities remain best in class to meet the challenging needs of the healthcare industry,” VistaMed managing director Patrick Mullholland…

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PreCardia receives FDA breakthrough device designation for catheter-based heart failure treatment

PreCardia today said it received FDA breakthrough device designation for its catheter-based system that treats volume overload in patients with acutely decompensated heart failure.

The PreCardia system is designed to rapidly and effectively reduce congestion in the venous system to improve overall cardiorenal function. Patient benefits can include an improved response to medical management, reduced re-hospitalizations and improved quality of life.

The system currently under investigation in an early feasibility study.

“PreCARDIA’s technology has achieved an important milestone in securing the FDA’s Breakthrough Device Designation. We are thrilled to move forward in our collaboration with the FDA, prioritizing our submission reviews and supporting rapid access to this therapy for ADHF patients,” president and CEO Lisa Wipperman Heine said in a news release.

Through the breakthrough device designation, the company Will have p…

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Miracor Medical PiSCO system wins CE mark

Miracor Medical this week said its Pisco Impulse Catheter and Pisco Impulse Console have received CE mark approval.

Pisco therapy is delivered by interventional cardiologists in a primary percutaneous coronary intervention procedure in patients that are experiencing anterior ST-elevated myocardial infarction.

The system works to reduce the infarct size by intermittently occluding the coronary sinus outflow leading to improved microcirculatory function.

Miracor Medical said the device has shown improvement of coronary microvascular function post-treatment with a significantly lower index of microcirculatory resistance at 24 to 48 hours when compared to controls.

“We are very excited to have CE Mark for the next-generation PiCSO Impulse System. This was an intense effort by everyone at Miracor and I wish to congratulate the Miracor team, our physician partners and clinical steering committee members for this achievement. The CE Mark is a great miles…

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BD launches Halo One thin-walled guiding sheath

Becton Dickinson (NYSE:BDX) has launched its Halo One Thin-Walled Guiding Sheath for peripheral arterial and venous procedures.

The device features a 1 Fr wall thickness sheath made from braided single-lumen tubing that is fitted with a female lure hub at the proximal end and a formed atraumatic distal tip. The thin wall reduces the size of the arteriotomy to minimize access site complications.

“The introduction of the Halo One Thin-Walled Guiding Sheath embodies our dedication to innovation, which for so long has centered on minimally invasive devices,” BD president of peripheral intervention Steve Williamson said in a news release. With Halo One Thin-Walled Guiding Sheath, we’re focusing on where those interventions begin, at the point of access. It effectively downsizes the access profile of peripheral procedures compared to standard sheaths, making it a valuable complement to our innovative portfolio of peripheral artery disease interventional d…

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