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FDA APPROVES SIEMENS ESWT

Posted by Ed Davis, DPM on 7/19/02 at 18:53 (090154)

The Siemens Sonocur has been approved by the FDA. It is the first office based unit. The availability of this modality will now take a quantum leap forward.
Ed

Re: FDA APPROVES SIEMENS ESWT

BrianG on 7/19/02 at 22:55 (090187)

Good!! The more ESWT machines in the USA, the better !!

Re: FDA APPROVES SIEMENS ESWT

DR Zuckerman on 7/20/02 at 18:21 (090231)

It this FDA approved for chronic plantar fasciitis.???? It is my understanding that it is only FDA approved for elbows. Has Siemans approved for a 510K for feet.

Re: FDA APPROVES SIEMENS ESWT

Sunny Jacob - Bayshore on 7/21/02 at 07:32 (090267)

For what procedure is this long anticipated FDA approval for Siemens Sonocur? Is it for PF or lateral epicondylitis?

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/21/02 at 23:29 (090324)

It is my understanding that the initial indication sought was for lateral epicondylitis. The Sonocur people seem to be using the machine in Canada for plantar fasciitis more than anything else. I will ask David Lowy for specifics.
Ed

Re: FDA APPROVES SIEMENS ESWT

DR Zuckerman on 7/22/02 at 06:28 (090334)

Ed,

I can purchase the soncur machine for plantar fasciitis treatment in the USA??

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/24/02 at 16:11 (090511)

Yes you can. The Siemens machine entered the market under the indication of lateral epicondylitis. As such, it has been marketed primarily to orthopedic clinics. Use of the Siemens Sonocur for PF would be an 'off label ' use for that machine specifically as use of Celebrex is for pain (it actually does not have a specific pain indication) or Neurontin for painfil neuropathy. I have no doubt that some third parties will quibble over coverage issues based on strict interpretation of specific 'indications' but that will be only a temporary hurdle.

We are probably getting close to the end of body region specific 'indications' for specific machines. It is the intent of the orthopedic clinics purchasing the Sonocur units to use the units for numerous tendinopathies and enthesopathies based on the info. I have. The orthopedic community has been avidly waiting a modality to treat more PF.
Ed

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/24/02 at 20:50 (090534)

Are you sure? It is my understand that yes an orthopedic surgeon who purchased it for elbows can use the soncur off label, however a podiatrist who purchases it for plantar fasciitis and not elbows can't. I remember back when the big O was being looked at by the FDA. I wanted to buy a dornier delta which is used for kidney stones but can't be marketed be used for ESWT.use
I wasn't able to buy the delta due to not being a urologist. I doubt that soncur markets the Soncur to podiatrists due to lack of Plantar fasciitis FDA approval.

From my experience if what you say is true then Healthronics and Dornier wasted millions of dollars getting pf FDA approval.

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/24/02 at 23:26 (090542)

Dr. Z,
Wouldn't treatment protocol be based on the laws that limits the practice of a Podiatrist to the foot, foot and ankle or in some states below the knee while an Orthopedic Surgeon M.D or D.O. is licensed to provide treatment to the entire human skeleton?

A Podiatrist by law would not be able to treat an elbow. They can't even use the title 'Physician' which is reserved for M.D.'s or D.O's. The term Doctor yes, but they cannot refer to themselves as a physician.

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 06:31 (090545)

Pauline,

A podiatrist is a physician by law and by Medicare definition. I have no
idea where you picked up the idea that a podiatrist isn't a physician. Now
back to ESWT. It is my opinion that soncur won't be able to sell soncurs
ESWT directly to podiatrist directly. Now if an orthopedic surgeon owns
that machine a podiatrist could use the machine . If a surgical center owned
the machine maybe a different story. The bottom line is the pathway has been
setup by the FDA .By the way to use ESWT equipment you have to be a board
certified orthopedic or podiatric physician.

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/25/02 at 09:28 (090556)

Dr.Z,
Here is where I read about the term 'physician' in #13. There were 25 question and answers posted by the state of N.Y. I assumed the answers sited were correct since they came from the state. I didn't post all 25
questions and answers. Just up to # 13.

According to Education Law, Article 130, section 6502, to practice in this State, all podiatrists must register with the New York State:
Education Department
Health Department
Office of Professional Discipline
Worker's Compensation Board

a. The New York State Education Department is authorized by law to regulate podiatry and 37 other licensed professions.

What is the function of the Office of Professional Discipline in relation to the practice of podiatry?
to convict professionals who commit State or Federal crimes
to set guidelines for practice
to monitor consumer complaints
to investigate and prosecute allegations of professional misconduct

d. The Office of Profession Discipline investigates and prosecutes all allegations of professional misconduct related to podiatry practice in New York. The Attorney General prosecutes consumer complaints.

According to Education Law, Article 130, section 6502, a license shall be valid during the life of the holder unless the:
Board of Regents revokes, annuls, or suspends the license
Education Department files charges against the licensee
licensee moves without proper notification
licensee practices less than one day per month

a. A license is valid during the life of the holder unless revoked, annulled or suspended by the Board of Regents.

According to Education Law, Article 130, section 6508, a board for each profession shall be appointed by the Board of Regents. The purpose of the State Board for Podiatry is to:
assist the Board of Regents and the Department on matters of professional licensing, practice and conduct
conduct investigations into misconduct
register or approve educational programs
review qualifications of all candidates for licensure

a. The State Boards for the Professions are committees of persons licensed in the profession plus at least one public representative who serve as advisors to the Board of Regents and the Department of Education on matters of professional licensing, practice and conduct.

According to Education Law, Article 130, section 6509, which one of the following does not constitute professional misconduct?
being convicted of a crime under New York State or Federal Law
permitting an unlicensed person to perform activities requiring a license
sharing professional fees with a partner authorized to practice the same profession
willfully failing to notify the Department of any change in name or mailing address

c. Regents Rule 29.1(b)(4) permits partners to share in the fees for professional services.

According to Regents Rule 29.2, a licensed professional is practicing proper infection control if:
direct patient contact is discontinued when the licensee has weeping skin lesions
gown and gloves only are donned if splattering blood is possible
sharp items are placed in the trash
the same protective equipment is used between patients

a. Regents Rule 29.2(13)(xii) requires licensees to refrain from all direct patient care when the licensee has exudative lesions or weeping dermatitis that has not been medically evaluated to be safe or capable of being safely protected against.

According to the Rules of the New York State Board of Regents, Part 29.1 and 29.2, which of the following conduct is lawful?
charging a fee for providing health records to a patient
refusing to make available to a patient copies of patient records
failing to wear an identification badge
offering bonuses for a professional service

a. Part 29.1 of the Rules of the Board of Regents states that it is unprofessional conduct for a licensee to fail to make available to a patient or client, upon request, copies of documents in their possession or under the control of the licensee. Part 29.2(b) also states that it is unprofessional conduct for licensees not to follow section 18 of the public health law. This section states that licensees may charge no more than 75 cents a page for paper copies of medical records. Podiatrists may charge the actual reproduction costs for radiographic materials, such as X-rays or mammograms. However, an individual cannot be denied access to information solely because s/he is unable to pay.

To qualify for a license as a podiatrist, an applicant must fulfill all of the following except:
file an application
complete a doctoral degree in podiatry
complete a one-year residency
pass a practical examination

d. Licensure as a podiatrist no longer requires completion of a practical examination.

The practice of podiatry includes:
treating any disease, injury, deformity or other condition of the foot
performing cutting operations on the malleoli
treating open wound fractures in an office
performing a physical examination required by school districts for students entering college

a. Section 7001, of Article 141 of Education Law, defines the practice of podiatry as: diagnosing, treating, operating and prescribing for any disease, injury, deformity or other condition of the foot and may include performing physical evaluations in conjunction with the provision of podiatric treatment. Podiatrists may treat traumatic open wound fractures only in hospitals, as defined in article twenty-eight of the public health law. The practice of podiatry shall not include treating any part of the human body other than the foot, nor treating fractures of the malleoli or cutting operations upon the malleoli.

Section 7001 of Article 141 permits podiatrists to:
administer nitrous oxide for deep sedation
administer local anesthesia for therapeutic purposes as well as for anesthesia
administer general anesthesia
administer local anesthesia for therapeutic purposes only

b. Section 7001 of Article 141 states that: The practice of podiatry shall include administering only local anesthetics for therapeutic purposes as well as for anesthesia and treatment under general anesthesia administered by authorized persons.

Which statement is true regarding podiatric prescriptions for medications?
prescriptions cannot be written for family members with non-podiatric conditions
a pharmacist does not have the right to question podiatric prescriptions
licensure in New York is a sufficient condition for podiatrists to prescribe medications
prescriptions do not need to include a patient's age

a. Podiatrists are limited to prescribing medications for the purpose of treating conditions of the feet.

Which statement is true regarding the administration of medications by podiatrists?
all podiatrists are permitted to administer or prescribe narcotics
drugs prescribed by a podiatrist may be given any route except intravenously
podiatrists are prohibited from providing conscious sedation in their office setting
podiatrists are limited to prescribing drugs for the purpose of treating conditions of the feet

d. Section 7001 of Article 131 of Education Law has been interpreted to imply that a podiatrist is limited to prescribing drugs for the purpose of treating conditions of the feet, despite the fact that the medications prescribed may also have other systemic effects.

A podiatrist in New York may be referred to by each title except:
a practitioner
a Doctor of Podiatric Medicine
a doctor
a physician

d. The title 'physician' is limited by law to individuals licensed under the profession of Medicine.

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 16:22 (090592)

Lateral epicondylitis

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 16:24 (090593)

New York is always different. In New Jersey where I practice we are physicians. We are under the state of medical examiners

Re: FDA APPROVES SIEMENS ESWT

john h on 7/25/02 at 17:03 (090596)

Dr. Zuckerman in Arkansas you are known as 'da man!'

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/25/02 at 19:00 (090605)

Good to know that I was posting correct information. I wonder how many other states have the same law.

I also noticed the laws applied to Dentistry in N.Y do not limit General Dentist like Podiatrist to only the use of local anesthesia. With proper credientials they can administer 3 different types. They are not as restricted. From advertisements I hear on the radio now many Dentists must have this same privlidge. Many are offering various sedation options for teeth repair for frightened patients.

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/25/02 at 19:39 (090608)

All ESWT manufacturers needed to obtain FDA approval for there machines via a specific indication and that is why Healthtronics and Dornier did not waste money on this. Sonocur, in obtaining approval for lateral epicondylitis opens the door for another use for the other ESWT machines to the best of my understanding. I could be wrong but it is hard to envision every new machine coming on the market being approved specifically one tendon in the body.
Ed

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/25/02 at 19:44 (090609)

Podiatric physicians are physicians by definition on a national basis. There are some states with antiquated laws like NY and California which restrict use of the term 'physician' for political reasons.
Ed

Re: ACIP

Ed Davis, DPM on 7/25/02 at 19:50 (090610)

I once attended a convention of the American College of International Physicians, an organization of foreign medical graduates, after being invited by a friend. I was stopped at the door and advised that the meeting was for foreign doctors only. The individual asked me what foreign county I was from. I replied 'California.' He let me in.
Ed

Re: ACIP

Joe S on 7/25/02 at 19:53 (090612)

hehehehe

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 22:22 (090631)

ED,

It should be that you don't have to do every tendon in the body but that is the way it is at present. This should in the future change. I believe that healthtronic has asked the FDA to open this up . But the way it looks now is soncur can't sell directly to the podiatry profession for the treatment of pf . This is my understand but things do change.

Re: ACIP

Dr. Zuckerman on 7/25/02 at 22:32 (090632)

Funny,

I like that one

Re: FDA APPROVES SIEMENS ESWT

Don Scott on 7/26/02 at 04:06 (090640)

Dornier EPOS Ultra uses in Australia are as follows
Plantar Fasciitis
Achilles Tentonitis
Haglund's Deformity
Patella Tendonitis
Greater Trochanter Bursitis
Medial and Lateral epicondolytis (Golfers and Tennis Elbow)
Calcium deposits on Shoulders
Non Union Fractures

Don

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/26/02 at 13:40 (090680)

Hard to say since I solicited the Sonocur people, not the other way around.
Washington State is dominated by 3 or 4 insurers that do not pay for ESWT so the pipeline for the Ossatron is narrow. It has been more economically feasible for cash patients to make the drive to Vancouver for the Sonocur.
It seems that PF is the main thing they are treating despite the marketing for lateral epicondylitis to the orthopedic community. My impression is that the ortho clinics will obtain the unit for lateral epicondylitis but the majority of the treatments wil be for PF.
Ed

Re: FDA APPROVES SIEMENS ESWT

Joe S on 7/26/02 at 14:54 (090692)

Ed,

what did the sonocur people say about leasing the machine or flat out buying it?

Joe

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/27/02 at 13:03 (090744)

Don:

Australia is way ahead of the US! This is what happens when an overzealous bureaucracy has so much power --- the public is harmed by an agency charged with its protection.
Ed

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/27/02 at 13:10 (090747)

Joe:

It is only available for lease, to the best of my knowledge. I do not know the purchase price.

The lease is a subvented lease with Sonocur supporting the price via a per use fee paid by the practitioner to Sonocur. The per month fee is kept reasonable. I really think that they will place a lot of machines with their business model. Siemens is a large corporation with a high manufacturing capacity and I think everyone may be surprised (and competing manufacturers worried) when the machines appear in large numbers of clinics and offices over the next year.
Ed

Re: APMA convention

Ed Davis, DPM on 7/27/02 at 13:15 (090748)

Joe:

Are you going to the APMA convention this August in Seattle? Sonocur is not exhibiting there but their clinic is not far away in Vancouver, BC.
I can give you directions or drive you up there for a look if you are interested. Vancouver has got to be one of the best cities in North America-- I am always looking for an excuse to visit.
Ed

Re: APMA convention

Joe S on 7/28/02 at 18:03 (090832)

I don't think I'm gonna make that one. I usually try and go to the ACFAS meetings. I may call them tomorrow (Sonocur).

Thanks

Re: FDA APPROVES SIEMENS ESWT

BrianG on 7/19/02 at 22:55 (090187)

Good!! The more ESWT machines in the USA, the better !!

Re: FDA APPROVES SIEMENS ESWT

DR Zuckerman on 7/20/02 at 18:21 (090231)

It this FDA approved for chronic plantar fasciitis.???? It is my understanding that it is only FDA approved for elbows. Has Siemans approved for a 510K for feet.

Re: FDA APPROVES SIEMENS ESWT

Sunny Jacob - Bayshore on 7/21/02 at 07:32 (090267)

For what procedure is this long anticipated FDA approval for Siemens Sonocur? Is it for PF or lateral epicondylitis?

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/21/02 at 23:29 (090324)

It is my understanding that the initial indication sought was for lateral epicondylitis. The Sonocur people seem to be using the machine in Canada for plantar fasciitis more than anything else. I will ask David Lowy for specifics.
Ed

Re: FDA APPROVES SIEMENS ESWT

DR Zuckerman on 7/22/02 at 06:28 (090334)

Ed,

I can purchase the soncur machine for plantar fasciitis treatment in the USA??

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/24/02 at 16:11 (090511)

Yes you can. The Siemens machine entered the market under the indication of lateral epicondylitis. As such, it has been marketed primarily to orthopedic clinics. Use of the Siemens Sonocur for PF would be an 'off label ' use for that machine specifically as use of Celebrex is for pain (it actually does not have a specific pain indication) or Neurontin for painfil neuropathy. I have no doubt that some third parties will quibble over coverage issues based on strict interpretation of specific 'indications' but that will be only a temporary hurdle.

We are probably getting close to the end of body region specific 'indications' for specific machines. It is the intent of the orthopedic clinics purchasing the Sonocur units to use the units for numerous tendinopathies and enthesopathies based on the info. I have. The orthopedic community has been avidly waiting a modality to treat more PF.
Ed

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/24/02 at 20:50 (090534)

Are you sure? It is my understand that yes an orthopedic surgeon who purchased it for elbows can use the soncur off label, however a podiatrist who purchases it for plantar fasciitis and not elbows can't. I remember back when the big O was being looked at by the FDA. I wanted to buy a dornier delta which is used for kidney stones but can't be marketed be used for ESWT.use
I wasn't able to buy the delta due to not being a urologist. I doubt that soncur markets the Soncur to podiatrists due to lack of Plantar fasciitis FDA approval.

From my experience if what you say is true then Healthronics and Dornier wasted millions of dollars getting pf FDA approval.

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/24/02 at 23:26 (090542)

Dr. Z,
Wouldn't treatment protocol be based on the laws that limits the practice of a Podiatrist to the foot, foot and ankle or in some states below the knee while an Orthopedic Surgeon M.D or D.O. is licensed to provide treatment to the entire human skeleton?

A Podiatrist by law would not be able to treat an elbow. They can't even use the title 'Physician' which is reserved for M.D.'s or D.O's. The term Doctor yes, but they cannot refer to themselves as a physician.

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 06:31 (090545)

Pauline,

A podiatrist is a physician by law and by Medicare definition. I have no
idea where you picked up the idea that a podiatrist isn't a physician. Now
back to ESWT. It is my opinion that soncur won't be able to sell soncurs
ESWT directly to podiatrist directly. Now if an orthopedic surgeon owns
that machine a podiatrist could use the machine . If a surgical center owned
the machine maybe a different story. The bottom line is the pathway has been
setup by the FDA .By the way to use ESWT equipment you have to be a board
certified orthopedic or podiatric physician.

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/25/02 at 09:28 (090556)

Dr.Z,
Here is where I read about the term 'physician' in #13. There were 25 question and answers posted by the state of N.Y. I assumed the answers sited were correct since they came from the state. I didn't post all 25
questions and answers. Just up to # 13.

According to Education Law, Article 130, section 6502, to practice in this State, all podiatrists must register with the New York State:
Education Department
Health Department
Office of Professional Discipline
Worker's Compensation Board

a. The New York State Education Department is authorized by law to regulate podiatry and 37 other licensed professions.

What is the function of the Office of Professional Discipline in relation to the practice of podiatry?
to convict professionals who commit State or Federal crimes
to set guidelines for practice
to monitor consumer complaints
to investigate and prosecute allegations of professional misconduct

d. The Office of Profession Discipline investigates and prosecutes all allegations of professional misconduct related to podiatry practice in New York. The Attorney General prosecutes consumer complaints.

According to Education Law, Article 130, section 6502, a license shall be valid during the life of the holder unless the:
Board of Regents revokes, annuls, or suspends the license
Education Department files charges against the licensee
licensee moves without proper notification
licensee practices less than one day per month

a. A license is valid during the life of the holder unless revoked, annulled or suspended by the Board of Regents.

According to Education Law, Article 130, section 6508, a board for each profession shall be appointed by the Board of Regents. The purpose of the State Board for Podiatry is to:
assist the Board of Regents and the Department on matters of professional licensing, practice and conduct
conduct investigations into misconduct
register or approve educational programs
review qualifications of all candidates for licensure

a. The State Boards for the Professions are committees of persons licensed in the profession plus at least one public representative who serve as advisors to the Board of Regents and the Department of Education on matters of professional licensing, practice and conduct.

According to Education Law, Article 130, section 6509, which one of the following does not constitute professional misconduct?
being convicted of a crime under New York State or Federal Law
permitting an unlicensed person to perform activities requiring a license
sharing professional fees with a partner authorized to practice the same profession
willfully failing to notify the Department of any change in name or mailing address

c. Regents Rule 29.1(b)(4) permits partners to share in the fees for professional services.

According to Regents Rule 29.2, a licensed professional is practicing proper infection control if:
direct patient contact is discontinued when the licensee has weeping skin lesions
gown and gloves only are donned if splattering blood is possible
sharp items are placed in the trash
the same protective equipment is used between patients

a. Regents Rule 29.2(13)(xii) requires licensees to refrain from all direct patient care when the licensee has exudative lesions or weeping dermatitis that has not been medically evaluated to be safe or capable of being safely protected against.

According to the Rules of the New York State Board of Regents, Part 29.1 and 29.2, which of the following conduct is lawful?
charging a fee for providing health records to a patient
refusing to make available to a patient copies of patient records
failing to wear an identification badge
offering bonuses for a professional service

a. Part 29.1 of the Rules of the Board of Regents states that it is unprofessional conduct for a licensee to fail to make available to a patient or client, upon request, copies of documents in their possession or under the control of the licensee. Part 29.2(b) also states that it is unprofessional conduct for licensees not to follow section 18 of the public health law. This section states that licensees may charge no more than 75 cents a page for paper copies of medical records. Podiatrists may charge the actual reproduction costs for radiographic materials, such as X-rays or mammograms. However, an individual cannot be denied access to information solely because s/he is unable to pay.

To qualify for a license as a podiatrist, an applicant must fulfill all of the following except:
file an application
complete a doctoral degree in podiatry
complete a one-year residency
pass a practical examination

d. Licensure as a podiatrist no longer requires completion of a practical examination.

The practice of podiatry includes:
treating any disease, injury, deformity or other condition of the foot
performing cutting operations on the malleoli
treating open wound fractures in an office
performing a physical examination required by school districts for students entering college

a. Section 7001, of Article 141 of Education Law, defines the practice of podiatry as: diagnosing, treating, operating and prescribing for any disease, injury, deformity or other condition of the foot and may include performing physical evaluations in conjunction with the provision of podiatric treatment. Podiatrists may treat traumatic open wound fractures only in hospitals, as defined in article twenty-eight of the public health law. The practice of podiatry shall not include treating any part of the human body other than the foot, nor treating fractures of the malleoli or cutting operations upon the malleoli.

Section 7001 of Article 141 permits podiatrists to:
administer nitrous oxide for deep sedation
administer local anesthesia for therapeutic purposes as well as for anesthesia
administer general anesthesia
administer local anesthesia for therapeutic purposes only

b. Section 7001 of Article 141 states that: The practice of podiatry shall include administering only local anesthetics for therapeutic purposes as well as for anesthesia and treatment under general anesthesia administered by authorized persons.

Which statement is true regarding podiatric prescriptions for medications?
prescriptions cannot be written for family members with non-podiatric conditions
a pharmacist does not have the right to question podiatric prescriptions
licensure in New York is a sufficient condition for podiatrists to prescribe medications
prescriptions do not need to include a patient's age

a. Podiatrists are limited to prescribing medications for the purpose of treating conditions of the feet.

Which statement is true regarding the administration of medications by podiatrists?
all podiatrists are permitted to administer or prescribe narcotics
drugs prescribed by a podiatrist may be given any route except intravenously
podiatrists are prohibited from providing conscious sedation in their office setting
podiatrists are limited to prescribing drugs for the purpose of treating conditions of the feet

d. Section 7001 of Article 131 of Education Law has been interpreted to imply that a podiatrist is limited to prescribing drugs for the purpose of treating conditions of the feet, despite the fact that the medications prescribed may also have other systemic effects.

A podiatrist in New York may be referred to by each title except:
a practitioner
a Doctor of Podiatric Medicine
a doctor
a physician

d. The title 'physician' is limited by law to individuals licensed under the profession of Medicine.

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 16:22 (090592)

Lateral epicondylitis

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 16:24 (090593)

New York is always different. In New Jersey where I practice we are physicians. We are under the state of medical examiners

Re: FDA APPROVES SIEMENS ESWT

john h on 7/25/02 at 17:03 (090596)

Dr. Zuckerman in Arkansas you are known as 'da man!'

Re: FDA APPROVES SIEMENS ESWT

Pauline on 7/25/02 at 19:00 (090605)

Good to know that I was posting correct information. I wonder how many other states have the same law.

I also noticed the laws applied to Dentistry in N.Y do not limit General Dentist like Podiatrist to only the use of local anesthesia. With proper credientials they can administer 3 different types. They are not as restricted. From advertisements I hear on the radio now many Dentists must have this same privlidge. Many are offering various sedation options for teeth repair for frightened patients.

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/25/02 at 19:39 (090608)

All ESWT manufacturers needed to obtain FDA approval for there machines via a specific indication and that is why Healthtronics and Dornier did not waste money on this. Sonocur, in obtaining approval for lateral epicondylitis opens the door for another use for the other ESWT machines to the best of my understanding. I could be wrong but it is hard to envision every new machine coming on the market being approved specifically one tendon in the body.
Ed

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/25/02 at 19:44 (090609)

Podiatric physicians are physicians by definition on a national basis. There are some states with antiquated laws like NY and California which restrict use of the term 'physician' for political reasons.
Ed

Re: ACIP

Ed Davis, DPM on 7/25/02 at 19:50 (090610)

I once attended a convention of the American College of International Physicians, an organization of foreign medical graduates, after being invited by a friend. I was stopped at the door and advised that the meeting was for foreign doctors only. The individual asked me what foreign county I was from. I replied 'California.' He let me in.
Ed

Re: ACIP

Joe S on 7/25/02 at 19:53 (090612)

hehehehe

Re: FDA APPROVES SIEMENS ESWT

Dr. Zuckerman on 7/25/02 at 22:22 (090631)

ED,

It should be that you don't have to do every tendon in the body but that is the way it is at present. This should in the future change. I believe that healthtronic has asked the FDA to open this up . But the way it looks now is soncur can't sell directly to the podiatry profession for the treatment of pf . This is my understand but things do change.

Re: ACIP

Dr. Zuckerman on 7/25/02 at 22:32 (090632)

Funny,

I like that one

Re: FDA APPROVES SIEMENS ESWT

Don Scott on 7/26/02 at 04:06 (090640)

Dornier EPOS Ultra uses in Australia are as follows
Plantar Fasciitis
Achilles Tentonitis
Haglund's Deformity
Patella Tendonitis
Greater Trochanter Bursitis
Medial and Lateral epicondolytis (Golfers and Tennis Elbow)
Calcium deposits on Shoulders
Non Union Fractures

Don

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/26/02 at 13:40 (090680)

Hard to say since I solicited the Sonocur people, not the other way around.
Washington State is dominated by 3 or 4 insurers that do not pay for ESWT so the pipeline for the Ossatron is narrow. It has been more economically feasible for cash patients to make the drive to Vancouver for the Sonocur.
It seems that PF is the main thing they are treating despite the marketing for lateral epicondylitis to the orthopedic community. My impression is that the ortho clinics will obtain the unit for lateral epicondylitis but the majority of the treatments wil be for PF.
Ed

Re: FDA APPROVES SIEMENS ESWT

Joe S on 7/26/02 at 14:54 (090692)

Ed,

what did the sonocur people say about leasing the machine or flat out buying it?

Joe

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/27/02 at 13:03 (090744)

Don:

Australia is way ahead of the US! This is what happens when an overzealous bureaucracy has so much power --- the public is harmed by an agency charged with its protection.
Ed

Re: FDA APPROVES SIEMENS ESWT

Ed Davis, DPM on 7/27/02 at 13:10 (090747)

Joe:

It is only available for lease, to the best of my knowledge. I do not know the purchase price.

The lease is a subvented lease with Sonocur supporting the price via a per use fee paid by the practitioner to Sonocur. The per month fee is kept reasonable. I really think that they will place a lot of machines with their business model. Siemens is a large corporation with a high manufacturing capacity and I think everyone may be surprised (and competing manufacturers worried) when the machines appear in large numbers of clinics and offices over the next year.
Ed

Re: APMA convention

Ed Davis, DPM on 7/27/02 at 13:15 (090748)

Joe:

Are you going to the APMA convention this August in Seattle? Sonocur is not exhibiting there but their clinic is not far away in Vancouver, BC.
I can give you directions or drive you up there for a look if you are interested. Vancouver has got to be one of the best cities in North America-- I am always looking for an excuse to visit.
Ed

Re: APMA convention

Joe S on 7/28/02 at 18:03 (090832)

I don't think I'm gonna make that one. I usually try and go to the ACFAS meetings. I may call them tomorrow (Sonocur).

Thanks