Heart

Main information

  • Trade name:
  • Heart valve prosthesis holder safety clip
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Heart valve prosthesis holder safety clip
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222056
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222056

LivaNova Australia Pty Ltd - Heart valve prosthesis holder safety clip

ARTG entry for

Medical Device Included Class Is

Sponsor

LivaNova Australia Pty Ltd

Postal Address

16 - 18 Hydrive Close,South Dandenong, VIC, 3175

Australia

ARTG Start Date

7/04/2014

Product category

Medical Device Class Is

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Sorin Biomedica Cardio SRL

Strada per Crescentino sn

Saluggia, VC, 13040

Italy

Products

1. Heart valve prosthesis holder safety clip

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

60835 Heart valve prosthesis holder safety clip

Intended purpose

A sterile device intended to be attached to a heart valve prosthesis holder during open surgical

implantation of a self-expandable heart valve bioprosthesis, to position, secure, and prevent accidental

release of the heart valve prosthesis holder's holding mechanism (e.g., holding sheath). It is a plastic

attachment with the appropriate size, shape and flexibility. This is a single-use device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 09.11.2017 at 10:55:54 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA - U.S. Food and Drug Administration

12-7-2018

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA Investigating Potential Connection Between Diet and Cases of Canine Heart Disease

FDA is alerting pet owners and veterinary professionals about reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods containing peas, lentils, other legume seeds, or potatoes as main ingredients.

FDA - U.S. Food and Drug Administration

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

7-6-2018

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Prevent Heartworms in Dogs, Cats, and Ferrets Year-Round

Heartworm disease can be fatal to pets, but it is also preventable. Learn more about the dangers of heartworm disease and the importance of year-round prevention.

FDA - U.S. Food and Drug Administration

4-6-2018

Medical Devices that Treat Obesity: What to Know

Medical Devices that Treat Obesity: What to Know

Obesity has been linked to many health problems, including heart disease, diabetes, and high blood pressure. Treatments for obesity range from healthy eating and exercise to prescription medicine and surgery. In recent years, FDA-regulated medical devices have also played a treatment role. Learn about approved products.

FDA - U.S. Food and Drug Administration

1-6-2018

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.

FDA - U.S. Food and Drug Administration

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

17-2-2014

Danish Pharmacovigilance Update 19 December 2013

Danish Pharmacovigilance Update 19 December 2013

In this issue of Danish Pharmacovigilance Update: Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®.

Danish Medicines Agency

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

Danish Medicines Agency

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Medicines Agency

5-7-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).

Danish Medicines Agency

14-6-2010

Changes in reimbursements for anti-ulcer medicines

Changes in reimbursements for anti-ulcer medicines

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.

Danish Medicines Agency

29-6-2018

High doses of MDMA can lead to a spike in body temperature that can result in heart failure or even death.  https://www.drugabuse.gov/publications/drugfacts/mdma-ecstasymolly …
#DrugFacts #FridayFactspic.twitter.com/tPDHYkvW43

High doses of MDMA can lead to a spike in body temperature that can result in heart failure or even death. https://www.drugabuse.gov/publications/drugfacts/mdma-ecstasymolly … #DrugFacts #FridayFactspic.twitter.com/tPDHYkvW43

High doses of MDMA can lead to a spike in body temperature that can result in heart failure or even death. https://www.drugabuse.gov/publications/drugfacts/mdma-ecstasymolly … #DrugFacts #FridayFacts pic.twitter.com/tPDHYkvW43

FDA - U.S. Food and Drug Administration

24-5-2018

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today!  http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonthpic.twitter.com/3teHPIlA40

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today! http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonthpic.twitter.com/3teHPIlA40

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today! http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonth pic.twitter.com/3teHPIlA40

FDA - U.S. Food and Drug Administration

15-5-2018

#DYK: Heart disease is the #1 killer of women? FDA is committed to helping women live longer by investing in heart health research. Learn more about FDA’s research about heart disease in women:  https://go.usa.gov/xQN43  #NWHW #SABVpic.twitter.com/UKwBQ7X

#DYK: Heart disease is the #1 killer of women? FDA is committed to helping women live longer by investing in heart health research. Learn more about FDA’s research about heart disease in women: https://go.usa.gov/xQN43  #NWHW #SABVpic.twitter.com/UKwBQ7X

#DYK: Heart disease is the #1 killer of women? FDA is committed to helping women live longer by investing in heart health research. Learn more about FDA’s research about heart disease in women: https://go.usa.gov/xQN43  #NWHW #SABV pic.twitter.com/UKwBQ7XoRO

FDA - U.S. Food and Drug Administration

15-5-2018

Take care of your heart. Share these 4 tips for better heart health:  http://go.usa.gov/xXG7h  #NWHWpic.twitter.com/h1j6iHmvny

Take care of your heart. Share these 4 tips for better heart health: http://go.usa.gov/xXG7h  #NWHWpic.twitter.com/h1j6iHmvny

Take care of your heart. Share these 4 tips for better heart health: http://go.usa.gov/xXG7h  #NWHW pic.twitter.com/h1j6iHmvny

FDA - U.S. Food and Drug Administration

15-5-2018

A healthy heart makes for a healthy you! Take time during #NWHW to take charge of your heart health. Read and share these tips:  http://go.usa.gov/xXG7h pic.twitter.com/U9BFWf72YY

A healthy heart makes for a healthy you! Take time during #NWHW to take charge of your heart health. Read and share these tips: http://go.usa.gov/xXG7h pic.twitter.com/U9BFWf72YY

A healthy heart makes for a healthy you! Take time during #NWHW to take charge of your heart health. Read and share these tips: http://go.usa.gov/xXG7h  pic.twitter.com/U9BFWf72YY

FDA - U.S. Food and Drug Administration