Modify eGFR value as per standard guidelines: CDSCO Panel Tells Hetero Lab on Antidiabetic FDC Drug

New Delhi: Reviewing the drug major Hetero Lab’s revised Phase III clinical trial protocol of fixed-dose combination antidiabetic drug Sitagliptin plus Metformin plus Voglibose, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has suggested that in the exclusion criteria, estimated glomerular filtration rate (eGFR) value should be modified as per the standard guidelines.

Furthermore, the expert panel suggested the firm submit the revised Phase III clinical trial protocol along with the bioequivalence (BE) report to the committee.

This came after Hetero Lab presented its proposal along with the revised Phase III clinical trial protocol before the committee.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar

Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.Metformin’s mechanisms of action are unique from other classes of oral antihyperglycemic drugs. Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization

Voglibose is an alpha-glucosidase inhibitor indicated in the management of postprandial blood glucose in patients with type II diabetes. Voglibose is used to reduce high post-meal glucose levels in diabetes mellitus in patients who have been using other diabetic medications. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Voglibose is an anti-diabetic medicine.

The hypoglycaemic action of voglibose results from a reversible inhibition of membrane-bound intestines α glycosidase hydrolase enzymes which hydrolize oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine.

At the recent SEC meeting endocrinology and metabolism held on 23 November 2023, the expert panel reviewed the proposal along with the revised Phase III clinical trial protocol of the antidiabetic drug Sitagliptin phosphate monohydrate plus Metformin HCl plus Voglibose film-coated tablet, presented by Hetero Lab.

After detailed deliberation, the committee recommended that in the exclusion criteria, the eGFR value should be modified as per the standard guidelines.

Accordingly, the expert panel suggested that the revised Phase III clinical trial protocol along with BE study reports should be presented before the SEC.

Also Read: Submit Justification to study Tocilizumab in patients with giant cell arteritis: CDSCO Panel Tells Cipla

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Over 5 crore ABHA accounts created at Ayushman Bhav Campaign

New Delhi: In a significant milestone, more than 5 crore ABHA accounts have been created during the ongoing Ayushman Bhava campaign. In addition, a total of 4,44,92,564 Ayushman cards have been generated and 1,15,923 Ayushman Sabha organized.

This is reflective of data up to 28.12.2023.

Under the ongoing Ayushman Bhav campaign, the cumulative footfall of Ayushman Arogya Mandir Melas and Community Health Centre Melas has reached 11,30,98,010 in 13,84,309 health melas till 28.12.2023.

Also Read:1.5 lakh patients get ABHA-based Scan and Share service at Noida’s DGCH hospital

The following activities are being carried out in the Health Melas:

Ayushman Arogya Mandir Melas: Ayushman Arogya Mandir have successfully organized and conducted 13,49,356 with a footfall of 9,76,56,060. The Melas included 9,21,783 wellness, yoga, meditations with 1,02,90,345 Tele consultations conducted. 6,41,70,297 people received free drugs and 5,10,48,644 people received free diagnostics services. 74,04,356 people received Ayush services and 10,99,63,891 were counselled for lifestyle activities. 45,43,705 Pregnant mothers registered in the first trimester and completed the first Absolute Neutrophil Count (ANC) Checkup and Immunization was provided to 29,83,565 mothers and 49,44,359 children. 7 types of screening (TB, Hypertension, diabetes, Oral Cancer, Breast Cancer, Cervical Cancer and Cataract) were conducted for 18,94,71,490 people. This data is reflected up to 28.12.2023.

Community Health Centre Melas (CHC): Community Health Centre Melas witnessed a registration of 1,54,41,950 people in 37,664 melas. 1,10,05,931 patients consulted general OPD while 49,67,675 patients consulted specialist OPD. 38,309 major surgeries and 1,30,760 minor surgeries have been conducted. This data is reflected up to 28.12.2023.

Also Read:761 hospital admissions worth Rs 1.12 crore approved under PMJAY for transgender beneficiaries: MoS Health Bhagel

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CDSCO Panel grants AstraZeneca’s Protocol Amendment Proposal for Sodium zirconium cyclosilicate

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment request presented by drug major AstraZeneca Sodium zirconium cyclosilicate.

This came after the firm presented Protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001. The study is to evaluate the effect of Sodium Zirconium Cyclosilicate on Arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

Sodium zirconium cyclosilicate is a potassium binder used to treat hyperkalemia.

Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure and may lead to cardiac arrest and death.

Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.

At the recent SEC meeting for the Cardiovascular and Renal held on 28 November 2023, the expert panel reviewed the protocol amendment version 3.0 dated 04 Apr 2023 Protocol no. D9487C00001

After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.

Also Read:Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet

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Investments worth Rs 25813 crore made under pharma PLI scheme as of Sept 2023, says Govt

New Delhi: Investments worth Rs 25,813 crore have been made and 56,171 new jobs were added as of September this year under the production-linked incentive scheme for pharmaceuticals, the government said on Friday. In its year-end review, the Department of Pharmaceuticals (DoP) also said the ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana‘ achieved its target of opening 10,000 retail outlets in 2023 to provide quality generic medicines at affordable prices to the poor and underprivileged.

The production-linked incentive (PLI) scheme for pharmaceuticals is being implemented with an objective of enhancing India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector.
The total outlay of the scheme is Rs 15,000 crore and the scheme duration is from 2020-2021 to 2028-29, an official statement said.
Under the Scheme, 55 applicants have been selected, which includes five applicants of In-vitro Diagnostics (IVD) devices with committed investment of Rs 17,275 crore.
Progress made under the scheme and as of September 2023, “investment worth Rs.25,813 crore has been grounded and employment for 56,171 persons have been generated”, it added.
“The sales made by the selected applicants is worth Rs 1,16,121 crore, which includes exports of Rs 75,141 crore. The scheme envisages manufacturing of a specialised category of pharmaceuticals/ IVD devices,” the statement said.
Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), the flagship scheme of the department, as on November 30, 2023, as many as 10,006 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) — retail outlets — have been opened across the country, it added.
In 2023, 206 medicines and 13 surgical equipment were added in the product basket of the scheme. Product basket of PMBJP comprises 1,965 medicines and 293 surgical equipment covering all major therapeutic groups such as anti-infectives, anti-diabetics, cardiovasculars, anti-cancers and gastro-intestinal medicines.
On the PLI scheme for promotion of domestic manufacturing of critical key starting materials (KSMs), drug intermediates (DIs) and active pharmaceutical ingredients (APIs) in India, DoP said a total of 249 applications across all four categories of products were received.
Out of 249 applications, 48 applications have been approved with committed investment of Rs 3,938.57 crore and expected employment generation of around 9,618 persons, it added.
As of September 2023, out of 48 approved projects, 27 projects have been commissioned. Investment of Rs 3,063 crore has been grounded and employment for 2,777 persons has been generated, the statement said, adding sales made by the commissioned projects are worth Rs 817.33 crore, including exports of Rs 252.62 crore.
Similarly, for the PLI scheme for medical devices that has a financial outlay of Rs 3,420 crore, a total 64 applications across four categories of products were received and 26 applications have been approved with committed investment of Rs 1,330.44 crore and expected employment generation for around 7,950 persons.
DoP said as of September 2023, out of the 26 approved projects, 16 projects have been commissioned and manufacturing of 39 medical devices has started with investment of Rs 879 crore grounded and employment generated for 4,546 persons.
“The sales made by the commissioned projects are worth Rs 3251.76 crore which includes exports of Rs 1654.09 crore,” it said.
In terms of FDI inflows in the pharmaceutical sector comprising both pharmaceuticals and medical devices — during the current financial year from April 2023 to September 2023, foreign investment stood at Rs.4,456 crore.
Further, the DoP has approved six FDI proposals worth Rs 9,848 crore for brownfield projects during April 1, 2023 to November 30, 2023, it said.

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PGIMER To Conduct Counselling For PhD Courses On 9th January

Chandigarh: The Postgraduate Institute of Medical Education and Research (PGIMER) has released the counselling schedule for admission to the course for the January 2024 session.

As per the notice, the counselling process will be conducted on 09.01.2024 at 12:00 Noon in the APC Auditorium, PGIMER, Chandigarh. The list of provisional qualified candidates on the basis of merit in the entrance exam will be displayed on the PGI website shortly.

Selected candidates must join their respective courses on the prescribed date, as indicated in their admission letters. The selection of those who fail to join by the specified date shall automatically stand cancelled.

Also Read:JIPMER Announces Conduction Of 1st Year Orientation Program For MD, MS, DM, MCH, MDS students

Admission to PhD courses offered at the Institute is done twice a year. The sessions commence in January and July each year. The admission to the PhD courses imparted at the Institute is made on an India Merit basis by holding an entrance examination by the Institute, after issuing a countrywide admission notice. The PhD courses are offered in the fields of Medical Sciences, Non-Medical/Life Sciences/Social Behavioral Sciences, Non-Medical/Life Sciences, and Social & Behavioral Sciences.

Postgraduate Institute of Medical Education and Research is a public medical university in Chandigarh and was conceived in 1960 as a centre of excellence. It has educational, medical research, and training facilities for its students, including all specialities, super specialities, and sub-specialities. Apart from the clinical services, PGI also provides training in almost all disciplines of Medicine, including postgraduate and post-doctoral degrees, diplomas, and fellowships. Admission to post-doctoral and postgraduate courses conducted at PGIMER is made twice a year. The sessions commence in January and July. Admission to the courses is made on merit on an all-India basis.

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/phd-counseling-notice-27dec2023162843-228903.pdf

Also Read:FMGE December 2023 applications Final Edit Window To Open tomorrow, details here

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BGS Gleneagles Kengeri Sets Record as First Hospital in Karnataka with 300+ Liver Transplants

Kengeri: BGS Gleneagles Kengeri proudly marks a momentous occasion as the first hospital in Karnataka to achieve 300+ successful liver transplants.   

This significant milestone is a testament to the unwavering dedication and collaborative efforts of the exceptional medical professionals and support teams.  

The hospital extends its deepest gratitude to the transplant surgeons, physicians, intensivists, anesthesiologists, nurses, coordinators, and all supporting staff who have played a pivotal role in nurturing the transplant ecosystem at BGS Gleneagles Kengeri over the past decade.

Also Read:Bharat Biotech, IHH Healthcare collaborate to provide Covaxin at Gleneagles Global Hospitals

Dr Suresh Raghavaiah, Chief Liver Transplant Surgeon, expresses his gratitude, stating, “This achievement is a testament to the relentless commitment of our team in ensuring the success of each transplant, giving patients a new lease on life.”

Dr Adarsh C K, Chief Transplant Hepatologist, emphasizes the importance of teamwork, saying, “The collaborative spirit among our professionals has been instrumental in reaching this milestone, showcasing the power of unity in healthcare.”

Dr Pradeep Krishna, Lead Liver Transplant Surgeon, commends the perseverance of the team, noting, “It is the dedication and resilience of every team member that has paved the way for 300 successful liver transplants, setting a benchmark in healthcare.”

Dr Pramod Kumar, Lead Transplant Hepatologist, reflects on the journey, stating, “This achievement reflects not only the expertise of our medical professionals but also the trust our patients place in us. It’s a shared victory for the entire BGS Gleneagles community.”

Biju Nair, Cluster COO, Gleneagles Bengaluru, acknowledges the collective effort, saying, “Our success is a reflection of the coordinated efforts of every individual across departments. Together, we have made a lasting impact on the lives of our patients.” 

As they celebrate this remarkable achievement, BGS Gleneagles Kengeri remains committed to advancing medical excellence and providing compassionate care to those in need. They look forward to continuing their journey of transforming lives through transplantation.

Also Read:Gleneagles Global Hospitals launch new program in Karnataka

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NExT for BHMS! Mandatory for Students Joining Internship After November 29

New Delhi: Introducing standardization in Homoeopathy education as well, the National Exit Test (NExT) has also been mandatory for the Bachelor of Homoeopathic Medicine and Surgery (BHMS) courses.

In this regard, the National Commission for Homoeopathy (National Examinations in Homoeopathy) Regulations, 2023 were published in the official Gazette of India on 22.11.2023 and the e-Gazette on 29.11.2023

Releasing a recent notice dated 14.12.2023, the National Commission for Homoeopathy has clarified that it is mandatory for the BHMS interns who have joined the internship on or after 29.11.2023 to appear in the National Exit Test.

“Qualifying of National Exit Test Examination and getting registered in a State or National Register shall be the essential requirement for practicing as a registered medical practitioner or for any job where clinical work is involved or for any job where medical registration is mandatory or to pursue post graduate programs in Homoeopathy,” mentioned the new regulations.

It was stated in the regulations that the NExT exam for the Homoeopathy courses shall ordinarily be conducted in the months of February and August every year.

While the NExT exam for Homoeopathy shall be held for granting license to practice as medical practitioner of Homoeopathy and for enrollment in the State or National Register, it is not going to replace the postgraduate entrance test for Homoeopathy courses.

As per the Regulations, the PG entrance test for Homoeopathy, All India Ayush Post-Graduate Entrance Test, shall be conducted by the National Commission for Homoeopathy every year in April or on the date specified by the Commission.

The National Commission for Homoeopathy (National Examinations in Homoeopathy) Regulations, 2023 were introduced by the National Commission for Homoeopathy, in exercise of the powers conferred by sub-section (1) and Clauses (h), (j), (k), (l), (m) and (n) of sub-section (2) of section 55 of the National Commission for Homoeopathy Act, 2020 (15 of 2020). “They shall come into force on the date of their publication in the Official Gazette,” mentioned the regulations.

National Exit Test:

The new regulations mentioned that a common National Exit Test for Homoeopathy shall be conducted by the Commission through designated authority as provided under sub section (1) of section 15 of the Act.

It further added that the NExT exam for Homoeopathy shall be held for granting license to practice as medical practitioner of Homoeopathy and for enrollment in the State Register or National Register as a registered medical practitioner of Homoeopathy.

Pattern of Examination: 

The pattern of the examination shall be problem based to test the clinical competency of a graduate of Homoeopathy as a registered medical practitioner in Homoeopathy, mentioned the Regulations.

Time-schedule for the Examination: 

As per the new NCH Regulations 2023, the National Exit Test examination for Homoeopathy shall be conducted ordinarily in the month of February and August every year.

Eligibility Criteria: 

Eligibility for appearing in the National Exit Test shall be as below:

(a) An intern who has completed minimum two hundred and seventy days of the internship by the last date for submission of application for the National Exit Test examination

(b) Graduates of Homoeopathy who have completed their internship

(c) Foreign Nationals whose medical qualification has been recognised in schedule III of Homoeopathy Central Council Act 1973 or Recognised as per section 36 of National Commission for Homoeopathy Act 2020. 

“However, the National Exit Test qualified candidates shall be eligible to get registered as medical practitioner only after completion of remaining duration of rotatory internship and fulfillment of criteria as specified by Board of Ethics and Registration for Homoeopathy,” clarified the Commission.

Who will Appear in NExT for Homoeopathy: 

In the Gazette notification, it was mentioned that the practitioners who have already been registered or have completed internship before the notification of the NCH Regulation 2023, need not appear for the NExT exam.

However, the Commission issued another notification on 14.12.2023 and mentioned, “…it is further to clarify that students who have joined internship before the date of publication of the above regulation in the gazette, need not appear in the National Exit Test. However, it is mandatory for interns who have joined internship on or after 29/11/2023 to appear in National Exit Test.”

“All State Registration Councils are hereby informed to continue registering eligible candidates accordingly if they have completed or joined their internship before 29/11/2023, and come to them for registration after completion of internship,” added the notification. 

“Date and other relevant details of the first National Exit Test shall be announced as per regulation and well in time,” the notice issued by NCH President Dr. Tarkeshwar Jain further mentioned.

Meanwhile, the newly notified regulations clarified that “As per sub-section (1) of section 15 of the National Commission for Homoeopathy Act 2020 (15 of 2020), without qualifying National Exit Test, no Homoeopathic graduate (Bachelor of Homoeopathic Medicine and Surgery) shall be eligible to get registered in the State or Union territory Administration or National register, as the case may be.”

The regulations further made it clear that “There shall not be any limit for attempts and duration to appear for National Exit Test” and “The candidates securing 50% and above shall be declared as qualified in National Exit Test Examination and the list of qualified candidates shall be displayed on the website of National Commission for Homoeopathy.”

What happens if a Candidate does not Clear NExT? 

In this regard, the new regulations mentioned that if a candidate does not clear the National Exit Test, his graduation degree shall be considered for all other job opportunities and other educational programs or courses where medical registration is not mandatory.

Explanation: Unlike all other graduation degree holders, this degree holder of Homoeopathy, who has not cleared the National Exit Test Examination shall not be eligible for medical practice, though they can appear for the jobs or post-graduation courses other than the post-graduate courses recognised by the Commission, where these degrees are recognised.

Apart from NExT for Homoeopathy, the newly notified regulations also discussed in detail the function and composition of the examination cell, duties and responsibilities of the controller and deputy controller of the examination, the details of the common advisory committee and technical committee, composition of the advisory committee, the terms of references of the advisory committee, composition and the terms of references of the technical committee, National Eligibility-cum-Entrance Test for Homoeopathy, All India Ayush Post Graduate Entrance Test, and National Teacher’s Eligibility Test.

To view the NCH Notification, click on the link below:

https://medicaldialogues.in/pdf_upload/nch-notification-229002.pdf

Also Read: NExT now mandatory after BAMS, BSMS, BUMS courses

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AIIMS Deoghar Releases Timetable For 1st Profesional MBBS Supplementary Exams 2022 Batch

Jharkhand: All
India Institute of Medical Sciences (AIIMS Deoghar) has released the timetable for the 1st professional MBBS supplementary examination 2022 batch.

The exams
are starting from 03-02-2024 and continue till 17-02-2024. The theory exams
will be conducted from 03-02-2024 to 14-02-2024, and practical exams will be
conducted from 15-02-2024 to 17-02-2024.

Detailed
schedule –

Theory –

Venue – Examination Hall, 2nd Floor, Academic Building, AIIMS, Deoghar.

DATE

DAY

TIME

SUBJECT

03-02-2024

Saturday

10:00 am
— 01:00 pm

Anatomy-
I

06-02-2024

Tuesday

10:00 am
— 01:00 pm

Anatomy-
II

08-02-2024

Thursday

10:00 am
— 01:00 pm

Physiology-
I

10-02-2024

Saturday

10:00 am
— 01:00 pm

Physiology-
II

12-02-2024

Monday

10:00 am
— 01:00 pm

Biochemistry-
I

14-02-2024

Wednesday

10:00 am
— 01:00 pm

Biochemistry-
II

Also Read:AIIMS Nagpur Releases PG Course 1st, 2nd Internal Assessment Exam Timetable

Practical:
– 9:30 am onwards – 

DATE

DAY

DEPARTMENT

15-02-2024

Thursday

ANATOMY

16-02-2024

Friday

PHYSIOLOGY

17-02-2024

Saturday

BIOCHEMISTRY

The list of
eligible candidates for the examination will be published tentatively on
18-01-2024 by the Academic Section. The candidates are directed to ensure that there are no dues in all departments, including the library, mess, etc.

Final
Notification of the examination process will be published on 20-01-2024. The
eligible candidates must submit the requisite examination fee of Rs. 1000/-,
till up examination form & admit card form from 27-01-2024 to 3 0-01-2024.

Only those
eligible students who have paid their examination fees in the account of AIIMS,
Deoghar, will be able to obtain their Hall Ticket/ Admit Card w.e.f. 31-01-202.4
onwards from the office of the undersigned/Exam Cell.

AIIMS Deoghar is a prestigious medical
university and hospital located in Deoghar, Jharkhand, India. It started
operation in 2019. The Institute operates autonomously under the Ministry of
Health and Family Welfare of the Government of India under the Pradhan Mantri
Swasthya Suraksha Yojna (PMSSY) and also among the Institutes of National
Importance in India.

To view the
notice, click on the link below –

https://medicaldialogues.in/pdf_upload/importantnoticeanddatesheetof1stprofmbbssupplementaryexam2022batch29122023050639160-229073.pdf

Also Read:AIIMS Kalyani Releases List Of Provisionally Ineligible Candidates For Externship Program

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Boston Scientific begins trial to evaluate Farapulse Pulsed Field Ablation System for Persistent Atrial Fibrillation

Marlborough: Boston Scientific Corporation has initiated the AVANT GUARD clinical trial to evaluate the safety and effectiveness of the FARAPULSE Pulsed Field Ablation (PFA) System* as a first-line treatment for persistent atrial fibrillation (AF).

Outcomes of ablation with the FARAPULSE PFA System – a nonthermal treatment in which electric fields selectively ablate heart tissue – will be compared to outcomes following use of anti-arrhythmic drug (AAD) therapy, which is commonly prescribed for patients living with persistent AF.

Unlike paroxysmal AF, which describes symptoms that last for seven days or fewer, persistent AF is a sustained arrhythmia that lasts for more than a week. Early treatment of persistent AF can reduce the risk of blood clots, stroke, and heart failure, and may prevent the disease from becoming permanent. Patients are often treated with AADs as frontline therapy for heart rhythm maintenance, though some can experience adverse effects and limited efficacy. Cardiac ablation is a potential alternative interventional strategy for those living with persistent AF.

“With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build,” said Dr. Brad Sutton, chief medical officer, AF Solutions, Boston Scientific. “The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the FARAPULSE PFA System as the preferred method for treating the disease.”

The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent AF at up to 75 sites globally. Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, and followed for three years. The trial will evaluate the outcomes of therapy provided with the FARAPULSE PFA System versus AADs, including device-or procedure-related adverse events, the rates of freedom from AF, atrial flutter, or atrial tachycardia, as well as AF burden – a measurement of the amount of AF an individual experiences.

All patients in the trial will also be inserted with the Boston Scientific LUX-Dx Insertable Cardiac Monitor. This device simplifies the monitoring process for patients by automatically capturing and transmitting arrhythmia episode data, and is designed to detect recurrence of cardiac arrhythmias and assess AF burden by providing continuous rhythm monitoring.

This week, the Cleveland Clinic enrolled the first patient in the AVANT GUARD trial, overseen by Dr. Oussama Wazni, vice chair of cardiovascular medicine and section head, Cardiac Electrophysiology and Pacing, Cleveland Clinic, who is also serving as the lead investigator of the trial.

Earlier this year, clinical trial data presented demonstrated the FARAPULSE PFA System is noninferior to standard-of-care therapies for the treatment of paroxysmal AF, with superior efficiency, while additional real-world data from more than 17,000 patients demonstrated continued real-world safety, efficacy and efficiency of the system. Boston Scientific also completed enrollment in the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023, which is studying the system for the treatment of patients with drug refractory symptomatic persistent AF, and commenced enrollment in an extension arm of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter.

The company now anticipates U.S. Food and Drug Administration approval of the FARAPULSE PFA System in the first quarter of 2024.

*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

Read also: Boston Scientific to acquire Relievant Medsystems

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Indian-origin doctor’s pandemic rock band gains popularity, has upcoming tour

London: An Indian-origin doctor with the UK’s state-funded National Health Service (NHS) decided to get musical over the COVID-19 pandemic lockdown, but what started as a one-man bedroom project has been gaining popularity with booked-out shows. 

Gulzar (Gulz) Singh Dhanoya, 25, started the indie-rock band named Gulz during his university days as a medical student. Now the lead vocalist and songwriter of the group has a four-member group made up of fellow NHS medical professionals. 

Also Read:Music training may improve attention and working memory in children: Study

“It was a lot easier when I was at university. I had a lot more time,” Gulz told the BBC Asian Network this week.

“I decided to release some stuff I’d been working on (over the pandemic). I was really nervous and I put it out on socials, then deleted it all off my phone for a week. I was worried my mates were going to give me stick for it. Luckily, it went pretty well,” he said.

Once some of his tracks got picked up by local radio stations, Gulz started getting offers to perform gigs. He then recruited friends from University College London (UCL) who went on to perform at sold-out shows all over London and now have a tour planned for 2024.

“It’s loud. It’s pop. It’s rough-round-the-edges. But it’s sweet,” reads their website.

Describing themselves as “doctors/rockers”, the band recently released their debut EP ‘Age of Youth’ with Fierce Panda Records – a label associated with some of the UK’s biggest bands such as Coldplay and Oasis. Working around their busy medical schedules is not easy but they are committed to making it work.

“We understand that the hospital patients always come first and the need to be a bit flexible with our rehearsals. Like one week, I’ll be on the night shift and then the next week someone else will. We can support each other a bit with that. And on days off, we just focus on the music,” he said.

He admits things do get stressful amid managing hospital rotas, but the music ultimately helps.

“Every time I play a gig – and it sounds really clichéd – I absolutely love it and it reminds me why I do it. There’s this buzz I get. We sacrifice a lot to do this, but it’s worth it,” he added.

He also supports the ongoing NHS junior doctors’ strike, which has been fighting for better pay and working conditions for many months now in pursuit of a better deal with the government.

“Neither industry is amazing for pay,” he notes.

Also Read:’New England Journal of Medicine’ Editor, Dr Rubin and Dr Jitendra Singh discuss future of medical research

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