Catheters

Affera, Inc. Announces Successful First-In-Human Use Of SpherePVI Circumferential Pulmonary Vein Isolation Device Using Pulsed Field Energy

Retrieved on: 
Tuesday, July 27, 2021
PVI, Arrhythmia, Medicine, Clinical medicine, Medical specialties, Sensei robotic catheter system, Catheters, Catheter ablation

WATERTOWN, Mass., July 27, 2021 /PRNewswire/ -- Affera, Inc ., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today first-in-human use of its circumferential Pulmonary Vein Isolation (PVI) Pulsed Field Ablation (PFA) catheter, SpherePVI.

Key Points: 
  • WATERTOWN, Mass., July 27, 2021 /PRNewswire/ -- Affera, Inc ., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today first-in-human use of its circumferential Pulmonary Vein Isolation (PVI) Pulsed Field Ablation (PFA) catheter, SpherePVI.
  • "The SpherePVI enables performance of circumferential PVI with minimal catheter manipulation and lesion applications.
  • SpherePVI is a novel 8F over-the-wire multi-segment lattice tip catheter designed to efficiently deliver circumferential pulmonary vein isolation.
  • The Affera system, SpherePVI and Sphere9 catheters are not currently approved for commercial use.

Venock Reports Safety/Efficacy of Its Automated Closure Device for Large Bore Venous Access Sites as Alternative to Standard Manual Compression of Veins/Arteries in Interventional Procedures

Retrieved on: 
Wednesday, July 21, 2021
Cardiology, Technology, Professional services, Health, General Health, Venture capital, Other Technology, Medical devices, Hospitals, Surgery, Hardware, Interventional radiology, Medical specialties, Medicine, Jugular vein, Vascular closure device, Clinical medicine, Catheters

Venock announced today it has successfully completed the demonstration of safety and efficacy of its large bore closure system in animal studies.

Key Points: 
  • Venock announced today it has successfully completed the demonstration of safety and efficacy of its large bore closure system in animal studies.
  • The Venock device (see animation ) was successfully used in multiple acute porcine studies to percutaneously close large bore access sites in the jugular vein.
  • Venock Inc. is a privately held US medical device company headquartered in New York City, with a subsidiary Venock Medical GmbH in Munich.
  • Its Vascular Closure Device is designed to close very large perforations that can be as big as the diameter of the operable vein or artery.

STARBOARD MEDICAL, INC. strengthens its intellectual property with issuance of new patent covering Clik-FIX Catheter Securement through 2038

Retrieved on: 
Monday, June 14, 2021
Catheters, Medicine, Peripherally inserted central catheter, Port, PICC, Central venous catheter

The awarded patent further strengthens the company's intellectual property portfolio, expanding its patent claims and solidifying new design improvements.

Key Points: 
  • The awarded patent further strengthens the company's intellectual property portfolio, expanding its patent claims and solidifying new design improvements.
  • 30.2% of all PICC (Peripherally Inserted Central Catheter) lines fail prematurely due to complications, the most widespread being dislodgement.
  • Clik-FIX catheter securement devices were specifically engineered to secure catheters better by minimizing the potential for pistoning and movement.
  • Starboard Medical is an innovator in catheter securement and patient temperature management, focused on developing progressive product designs that significantly improve product performance, safety, and outcomes.

Cardiovascular Systems, Inc. Announces U.S. Commercial Launch of JADE Over-the-Wire Non-Compliant Peripheral Balloon Catheters

Retrieved on: 
Tuesday, June 1, 2021
Health, Medical devices, Cardiology, Manufactured goods, Catheters, Interventional radiology, Goods economics), Balloon catheter, Stent, Balloon, Toy balloon, Peripheral Artery Disease (PAD), Cardiovascular Systems, Inc., OrbusNeich, PERIPHERAL ARTERY DISEASE (PAD), CARDIOVASCULAR SYSTEMS, INC., ORBUSNEICH

JADE is an OTW balloon catheter for PTA in the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae, as well as for post-dilatation of balloon expandable and self-expanding stents.

Key Points: 
  • JADE is an OTW balloon catheter for PTA in the peripheral vasculature, including obstructed native arteries and synthetic arteriovenous dialysis fistulae, as well as for post-dilatation of balloon expandable and self-expanding stents.
  • JADE is a non-compliant balloon designed for high pressure tolerance and balloon dilatation with even pressure distribution for the treatment of complex lesions.
  • The predictable, uniform inflation of these non-compliant balloons allows for accuracy in balloon sizing and reduces the potential for vessel recoil.
  • Said Dr. Rao, The deliverability of the JADE balloons, whether it be on the 0.014, 0.018 or 0.035 platform, is exceptional.

IRRAS Announces publication of a Case report from Buffalo General Medical Center, highlights clinical superiority of IRRAflow treatment versus traditional drainage

Retrieved on: 
Friday, May 28, 2021
Medical specialties, Medicine, Catheters, Medical equipment, Clinical medicine, Intraventricular hemorrhage, Neurotrauma, Port, External ventricular drain

Also, it was noted that "our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD."

Key Points: 
  • Also, it was noted that "our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD."
  • "Even more importantly, when a world-leading institution such as Buffalo General Medical Center highlights clearly superior performance of IRRAflow compared to passive drainage techniques, it validates the system's impact and sets the stage for broadened adoption."
  • The case report highlights treatment using the IRRAflow fluid management system for a patient suffering from IVH at Buffalo General Medical Center in Buffalo, NY.
  • During this patient treatment, an IRRAflow catheter was placed into the patient's right ventricle and provided drainage without interruption throughout patient treatment.

IRRAS Announces publication of a Case report from Buffalo General Medical Center, highlights clinical superiority of IRRAflow treatment versus traditional drainage

Retrieved on: 
Friday, May 28, 2021
Medical specialties, Medicine, Catheters, Medical equipment, Clinical medicine, Intraventricular hemorrhage, Neurotrauma, Port, External ventricular drain

Also, it was noted that "our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD."

Key Points: 
  • Also, it was noted that "our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD."
  • "Even more importantly, when a world-leading institution such as Buffalo General Medical Center highlights clearly superior performance of IRRAflow compared to passive drainage techniques, it validates the system's impact and sets the stage for broadened adoption."
  • The case report highlights treatment using the IRRAflow fluid management system for a patient suffering from IVH at Buffalo General Medical Center in Buffalo, NY.
  • During this patient treatment, an IRRAflow catheter was placed into the patient's right ventricle and provided drainage without interruption throughout patient treatment.

Global Peripheral Intravenous Catheter Market to Surpass US$ 7,272.8 Million by 2027, Says Coherent Market Insights (CMI)

Retrieved on: 
Friday, May 21, 2021
Medical devices, Health, Hospitals, Other Health, Cardiology, Biotechnology, Catheters, ICU Medical, Peripheral venous catheter

Moreover, according to the same source, around 2 million people worldwide suffer from end stage renal disease (ESRD).\nMoreover, increasing approval of novel products is expected to drive the market growth over the forecast period.

Key Points: 
  • Moreover, according to the same source, around 2 million people worldwide suffer from end stage renal disease (ESRD).\nMoreover, increasing approval of novel products is expected to drive the market growth over the forecast period.
  • For instance, in March 2018, Smiths Medical received the U.S. FDA clearance for its DeltaVen Closed System Catheter, a product developed by Delta Med SpA.
  • For instance, in November 2019, ICU Medical, Inc. acquired Pursuit Vascular, a medical device manufacturing company.
  • As a result of this acquisition, ICU Medical, Inc. expanded its catheter portfolio in the global market.\nThe global peripheral intravenous catheter market is expected to exhibit a CAGR of 6.1% over the forecast period, owing to increasing incidence of chronic diseases such as cardiovascular diseases, which is expected to drive the market growth over the forecast period.

CorMedix Inc. to Participate at the 7th Annual Truist Securities Life Sciences Summit

Retrieved on: 
Wednesday, April 28, 2021
Medicine, Clinical medicine, Catheters, Medical specialties, Central venous catheter, Parenteral nutrition, Food and Drug Administration, Bloodstream infections, Hemodialysis, Peripheral venous catheter, Lipoglycopeptide

The Company is focused on developing its lead product DefenCath\xe2\x84\xa2, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.

Key Points: 
  • The Company is focused on developing its lead product DefenCath\xe2\x84\xa2, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.
  • DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need.
  • QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients.

Analytica Announces Expansion of Enhanced Infusion System into Middle East

Retrieved on: 
Tuesday, April 27, 2021
Medical technology, Equipment, Medicine, Dosage forms, ICU Medical, Infusion pump, Catheters, Port, EIS

The EIS reacts immediately, silently and without intervention or programming.

Key Points: 
  • The EIS reacts immediately, silently and without intervention or programming.
  • It can be retrofitted to any existing infusion system design and can work in harmony with and improve the capability of any infusion pump or \xe2\x80\x98bag\xe2\x80\x99 infusion system, regardless of sophistication.\nUse of the EIS uniquely allows a completely closed infusion system, with integrity achieved by reducing the interactions believed to cause mechanical and vascular complications as well as good flushing and/or patency practice.\nThe EIS has an Australian TGA ARTG registration and USFDA 510(k) clearance.
  • EIS limits access and infection opportunity.\nFlushing pressure \xe2\x80\x93 Bolus flush of catheter may vary based on syringe size and pressure.
  • This affects 1 in 3 women worldwide and is mostly caused by trauma to the pelvic floor muscles because of pregnancy, childbirth and menopause.\n\xc2\xb9 Trademark of ICU Medical Australia.\n'

NanoVibronix Announces Start of Real World Patient Study of UroShield

Retrieved on: 
Monday, April 19, 2021
Medical devices, Health, Catheters, XC2, Port, Medicine, Southern Health NHS Foundation Trust, NanoVibronix, Inc., SOUTHERN HEALTH NHS FOUNDATION TRUST, NANOVIBRONIX, INC.

There are also an additional 154,000 patients hospitalized annually who are catheterized for more than 48 hours and are also at risk for infection.

Key Points: 
  • There are also an additional 154,000 patients hospitalized annually who are catheterized for more than 48 hours and are also at risk for infection.
  • Patient recruitment has started and is expected to include up to 30 total real-world patients who have a history of catheter infections, blockages and pain and have not previously used the UroShield device.
  • The Company\xe2\x80\x99s primary products include PainShield\xc2\xae, UroShield\xc2\xae and WoundShield\xc2\xae, all of which are portable devices suitable for administration at home without assistance of medical professionals.
  • Investors and security holders are urged to read these documents free of charge on the SEC\xe2\x80\x99s web site at: http://www.sec.gov .