Embolic Protection Devices during percutaneous cardiac procedures (PCI and TAVI)

Series
Cardiovascular
Status
Ongoing
Date
Number of report
060

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The report presents a summary of reimbursement situation for use of Embolic Protection Devices during percutaneous cardiac procedures. 


The following clinical situations are considered: 

  • Use of Embolic Protection Device during percutaneous transluminal coronary angioplasty with insertion of single bare metal stent
  • Use of Embolic Protection Device during percutaneous transluminal transcatheter aortic valve replacement

The only reimbursement within public / statutory health insurance systems is considered.

Report includes essential information about reimbursement and national funding, including:

  • Brief overview of reimbursement system for medical devices
  • Procedure coding for technology
  • Diagnosis coding
  • Payment mechanism for technology
  • Reimbursement tariffs for technology
  • Restrictions in indications or scenarios for use of technology
  • Policy considerations by payers and policy-makers about technology

Reimbursement information is provided for the following geographies:

  • Austria
  • Belgium
  • Denmark
  • England (UK)
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • Switzerland

Manufacturers of Embolic Protection Devices for percutaneous cardiac procedures (PCI and TAVI):

  • Allium Medical (WIRION EPD)
  • Boston Scientific (FilterWire EZ)
  • Claret Medical (Sentinel)
  • Contego Medical (Corguard)
  • Cordis (ANGIOGUARD)
  • Innovative Cardiovascular Solutions (Emblock)
  • Keystone Heart Ltd (TriGuard)
  • Transverse Medical (POINT-GUARD)

Table of content is not available at the moment. Report is still ongoing.

20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

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14

May 2019

The report presents a summary of reimbursement situation for use of Embolic Protection Devices during percutaneous cardiac procedures (PCI and TAVI). The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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01

Mar 2019

Eleven new DRGs have been added in 2019, while three DRGs have been deleted. The significant changes have been made for disorders of the circulatory organs (MDC 5) and musculoskeletal, skeletal and connective tissue disorders associated with prosthetic surgery (MDC 8). They concern insertion of vagus stimulator, ablation of heart, percutaneous valve replacement, and others.

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20

Feb 2019

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

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17

Jan 2019

In late December 2018, the European HTA agency, EUnetHTA, announced the final report of the project OTCA06 - “Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk.”

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11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

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19

Dec 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in November 2018 concern various types of devices. The decisions were brought for twenty-two (22) medical devices.

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18

Oct 2018

In May 2018, the French National Authority of Health, HAS, has published an update of the assessment of coronary stents.

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10

Oct 2018

EUnetHTA is a network of HTA bodies within Europe that promote the development of health technology assessment in all European countries by working together. This article will present the plans for the projects that will be published in the near future.

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04

Sep 2018

At the end of June of 2018, the National Board of Health and Welfare (Socialtyrelsen) has published an updated version of the National clinical guidelines for heart care. The review was conducted for the inclusion of few updated recommendations regarding the management of the coronary heart disease, valvulopathy and arrhythmia.

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31

Jul 2018

Minister of Health announced that it is planned to re-equip 609 vascular surgery centers. In parallel, about 30 departments will be upgraded to the level of the regional vascular centers, which will increase their capacity. Ministry plans that these efforts will help to double number of primary coronary interventions in acute coronary syndrome in Russia.

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11

Jun 2018

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

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31

May 2018

In the first half of May, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for percutaneous balloon valvuloplasty for fetal critical aortic stenosis and three new medtech innovation briefings for patient position monitoring system for intracranial stereotactic radiosurgery, 3D/QFR imaging software to assess coronary fractional flow reserve non-invasively and point-of-care tests for diagnosing group A beta-haemolytic streptococcus (strep A) throat infection.

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15

Mar 2018

The German Federal Joint Committee (G-BA) has commissioned the Institute for Quality Assurance and Transparency in Health Care (IQTIG) to evaluate the guideline on minimally invasive heart valve interventions with minimum quality standards for hospitals that want to perform transcatheter aortic valve implantation (TAVI) or clip procedures on the mitral valve. The report has to be submitted by December, 2019.

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02

Jan 2018

A 150-page reimbursement report covers angiography, intravascular ultrasound (IVUS), fractional flow reserve (FFR), cardiac computer tomography (CCT), optical coherence tomography (OCT) for angina and myocardial infarction in hospital settings. Stand-alone application of imaging / diagnostic methods and use in conjunction with percutaneous coronary intervention procedure was considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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30

Nov 2017

A 155-page reimbursement report covers coronary angioplasty (using a plain and drug-coated balloon, bare metal, drug-eluting and bioresorbable stents), mechanical thrombectomy and atherectomy in hospital settings. The analysis covers procedure coding, payment mechanism, reimbursement tariff and policy restrictions. The report provides an overview of reimbursement situation in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

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27

Nov 2017

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

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22

Nov 2017

The Austrian HTA body LBI-HTA performed a systematic review of health economic evaluations of Transcatheter Aortic Valve Implantation (TAVI) compared to medical treatment and surgical aortic valve replacement for inoperable and operable patients with high or moderate surgical risk. The result of the review have only limited transferability to Austria, and LBI-HTA concluded, that the currently applied selection of patients based on clinical parameters can be considered as good practice.

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20

Nov 2017

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

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03

Nov 2017

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

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17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

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03

Oct 2017

New procedure codes will be created for stem cell procedures, extracorporeal techniques (including hemodialysis and CO2 removal), surgical interventions, including growth-controlling spinal correction, transposition of peripheral nerve, interventions on veins, and percutaneous image-guided procedures (including code for pressure measurement in coronary arteries and additional code for drug-eluting balloon). Classification will be enabled from January 1, 2018.

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06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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03

Jul 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 8 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include coronary stents, portable oxygen concentrators, Urolift device, spinal ganglion stimulator and insulin pumps.

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04

Apr 2017

NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance). Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017.

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30

Mar 2017

Our analysis of creation of procedure codes for TAVI in 11 European markets shows different speed in creation of codes, but in general it was a quick process (1.8 years on average). However, in all markets, availability of procedure code did not automatically lead to reimbursement or appropriate reimbursement.

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20

Mar 2017

MTRC has released reimbursement report for transcatheter aortic valve implantation in 11 European countries. Report includes information about procedure coding, payment mechanisms, reimbursement tariffs and policies for TAVI.

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15

Mar 2017

MTRC is working on release of 9 reimbursement reports for medical technologies during March 2017, including report for transcatheter aortic valve replacement and eight minimally invasive mitral valve repair and replacement procedures.

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