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Biomedical subjects

M H Wholey

Publications and source records attributed to M H Wholey.

101 records · Page 6Linked to original sources
PubMedDate not supplied

The design and clinical application of a new #5 French angioplasty catheter.

Although major technological advances have occurred in coronary artery angioplasty balloons and steerable wire systems, there have been surprisingly few advances in the development and designs for balloons in the peripheral circulation. For example, a #7 French shaft has become the standard for most peripheral as well as visceral angioplasty balloons. In most instances, the shaft is unnecessarily large and not only interferes with tractability over the conventional wire but in certain situations is also unnecessarily traumatic to the vascular intima as the catheter is passed to the angioplasty site. For these reasons a newly designed catheter with a shaft measuring 1.67 mm (#5 French) has been designed to incorporate a variety of dimensional balloons varying from 2 mm through 7 mm. In addition, the open end allows passage of a .035 inch wire and consequently the balloon is ideally suited for applications from vessels as small as the tibial circulation or renal visceral or iliac circulation.

Angioplasty, Balloon↗
PubMedDate not supplied

Infrainguinal directional atherectomy: long-term follow-up and comparison with percutaneous transluminal angioplasty.

PURPOSE: To assess the long-term results of directional atherectomy (DA) for femoropopliteal artery atherosclerotic lesions and to compare the results to those previously reported for percutaneous transluminal balloon angioplasty (PTA). MATERIALS AND METHODS: Eight-four percutaneous DA procedures performed on 75 patients between July 1988 and August 1992 were retrospectively reviewed and evaluated for technical and initial clinical success. Long-term patency was assessed with a combination of ankle-brachial index measurements and angiography. RESULTS: Initial technical success was achieved in 77 of 84 procedures (92%). Follow-up of 72 patients was obtained, including 74 of the 84 (88%) DA procedures with a mean follow-up of 17.4 months (range 1-48 months). Primary patency was 78% at 1 year and 57% at 2 years. Patients with diabetes, complete luminal occlusion, or limb salvage situations had significantly lower patency. CONCLUSIONS: Femoropopliteal artery DA can be performed safely with a high technical and initial clinical success. Long-term patency is improved when compared with published series for PTA. With this improvement in mind, DA may have a place in the treatment of focal infrainguinal stenoses.

Actuarial Analysis↗
PubMedDate not supplied

Antegrade popliteal puncture: technical note.

Percutaneous transluminal angioplasty was performed via an antegrade popliteal puncture. This technique was utilized because the patient had a superficial femoral artery occlusion and coexistent popliteal stenoses, with the occlusion unable to be traversed in the usual common femoral artery antegrade approach. To our knowledge, this technique has not been described in the literature. The clinical utility of this approach and important anatomical considerations will be discussed.

Angioplasty, Balloon↗
PubMedDate not supplied

An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy.

Most physicians, and certainly the lay public, have only limited knowledge of the responsibilities and limits of the Food and Drug Administration (FDA) of the United States of America. Although laws as early as 1902 protected the public from unrestricted sale of unsafe drugs, it was not until 1976 that devices came under regulation. An obvious difference existed between regulatory control of drugs vs devices. The drug-based approach for evaluation was rejected in favor of a new system based on device class and its degrees of risk. The premarket notification process (510K), and the premarket approval application (PMAA) became the regulatory pathway for device approval. The investigational device exemption (IDE) became the mechanism for established safety and efficacy. Occasionally conflicts exist between industry and the FDA. Submission of poorly planned studies wastes FDA resources whereas prolonged approval times can be devastating to the small single product business that creates the majority of our new devices. A compromise is obviously necessary if we are to maintain our premier identity as a new device entrepreneurial center and avoid industry's migration to countries where the regulatory standards might be less rigid.

Equipment Design↗
PubMedDate not supplied

Retrieval of migrated colonic stents from the rectum.

Palliative stenting of malignant colonic obstruction may be complicated by stent migration. Stents that migrate into the rectum cannot be passed with bowel movements and frequently cause obstruction. We present two simple means to retrieve stents from the rectum using fluoroscopic guidance. These techniques were used successfully without complication in four stent migrations.

Colonic Neoplasms↗