Surgical Science, 2011, 2, 442-445
doi:10.4236/ss.2011.29096 Published Online November 2011 (
Copyright © 2011 SciRes. SS
Novel Suture-Less Vascular Anastomotic Device (BY Fi x) in
Femoro-Popliteal Surgery, Early Clinical Experience
M. Schneider1, V. Shapira2, V. Chernyavskiy3, B. Yoffe4
1Department of Vascul a r Sur gery, Erfurt Helios Clinic, Erfurt, Germany
2Department of Neurosurgery, RAMBAM Medical Center, Haifa, Israel
3Department of Vascul a r Sur gery, General Hospital, Irkutsk, Russia
4Department of Vascul a r Sur gery, Barzilay Hospital, Ashkelon, Israel
Received July 28, 2011; revi sed Octobe r 13, 2011; accepted October 31, 2011
Objectives: To evaluate the early experience of using the BYFix-innovative anastomotic device for creating
suture-less vascular anastomosis in major and peripheral arteries surgery. Design: Uncontrolled prospective
study. Materials: The BYFix anastomotic device for suture-less vascular anastomosis with surgical tools
and standard vascular grafts. Methods: 7 patients, age 63.6 ± 9.2 years, with peripheral vascular occlusion
above the knee scheduled for surgical repair were operared. They underwent the surgical procedure using the
BYFix anastomotic device for creating proximal anastomosis and the conventional manual suturing for cre-
ating the distal anastomosis of the implantable vascular graft. Results: The anastomoses by using BYFix
anastomotic device were successfully created in all patients. The duration of anastomosis creation was sig-
nificantly shorter by using BYFix device, compared to conventional manual suturing, 5:10 ± 1:50 minutes
compared to 33 ± 17:40 minutes respectively. No adverse events related to BYFix anastomotic device were
observed, during the surgical procedure or recovery period. One year follow up revealed no complications
related to BYFix anastomotic device. Conclusions: The BYFix anastomotic device enables the creation of
efficient vascular anastomosis in peripheral vascular occlusions. It shortens the time needed for creating
vascular anastomosis and thus reducing the operation time and might reduce distal complications related to
the vascular procedure. Further clinical trials are needed to establish the results.
Keywords: Anastomosis, Peripheral Vascular Surgery, BYFix Device
1. Introduction
Lower extremity peripheral arterial disease affects a
large proportion of most adult populations worldwide [1].
The prevalence of lower extremity peripheral arterial
disease has been defined by a series of epidemiological
investigations, that have used either claudication as a
symptomatic marker of lower extremity peripheral arte-
rial disease, or an abnormal ankle-to-brachial systolic
blood pressure to define the population affected [2].
Patients with symptomatic PAD have significantly re-
duced mobility and poor quality of life, claudicating re-
sults in a reduced physical component quality of life
score-lower than for arthritis, cancer or chronic lung dis-
ease [3].
Furthermore, PAD patients were more likely to have
widespread atheromatous disease in multiple vascular
beds (62%), than patients with either CHD (25%) or
stroke (40%) [4]. As the presence of PAD is a red alert
for the existence of widespread atherothrombosis it
should provide a powerful stimulus for action. However,
despite these compelling statistics, PAD remains under
diagnosed and patients often do not get proper care until
the associated heart disease becomes evident. Progres-
sion of PAD can result in critical limb ischemia, mani-
fested by ischemic pain at rest or in breakdown of the
skin (ulcers or gangrene). Severe PAD can result in tis-
sue ischemia in the lower extremities, causing gangrene
and requiring amputation in 3% to 8% of patients [5,6].
Aggressive investigation for revascularization options,
either surgical or percutaneous, are warranted in such
instances. Only a small proportion of patients with severe
disease ultimately require a major amputation.
In managing PAD, it is critically important to deal
with the high risk of developing severe and often fatal
cardiovascular complications. The first priority is to ag-
gressively modify risk factors that enhance the progres-
sion of atherosclerosis and atherosclerotic complications.
Treatments may include lifestyle modification; smoking
cessation; dietary management to decrease weight and
control serum lipid levels; physical training and exercise
therapy are recommended for patients with intermittent
claudication. Antiplatelet and lipid-lowering therapies
are effective in decreasing the risk of cardiovascular
morbidity and improving long-term survival, endovascu-
lar treatment and bypass surgical intervention [7].
The goal of surgical intervention in patients is the
elimination of clinical manifestations of severe lower
extremity peripheral arterial disease, whether rest pain,
ischemic ulcers, or distal ischemic gangrene. Surgery for
the treatment of severe lower extremity ischemia (as for
endovascular treatment) must be based on specific goals,
such as the relief of rest pain or healing of ulcers, prior
revascularization attempts, the type of procedure re-
quired to accomplish the goals, and the patient’s overall
ability to successfully recover from the effort.
The innovative BYFix device (HDH Medical, Israel)
and method are intended for creating sutureless vascular
anastomosis, and by that reduction surgery complication,
thus improves the effectiveness of the surgical proce-
dures on various blood vessels.
2. Materials and Methods
2.1. Study Design
This study is a prospective, multi-center and uncontrolled.
Three centers in Germany, Israel and Russia have par-
ticipated in the study.
2.2. Patients
During the period from January 2008 until November
2009, 7 patients had been enrolled in the study, 3 in Ger-
many, 2 in Israel and 2 in Russia. All patients were di-
agnosed to have peripheral vascular occlusion above the
knee, scheduled for occlusion surgical repair and fulfill
the inclusion criteria of the study: diameter of femoral
artery 5 mm, patient with severe stenosis or occlusion
of SFA (superficial femoral artery) requiring femoral-
popliteal bypass above the knee, artery that is relatively
free of calcium and atheromathosis, TACS II-C, D,
Fontaine IIb, ASA I, II, III and patient’s physical condi-
tion allows performing general anesthesia.
All patients signed informed consent form.
The study protocol was approved by the local ethical
committee at each medical center as well as by the ethi-
cal committee of Ministry of Health in Israel.
2.3. The BYFix Device
The BYFix device is intended for creating sutureless
vascular anastomosis in various blood vessels (Figures 1,
The BYFix device is accompanied with tools for its
insertion: the measuring device (Figure 3) and the inver-
sion device (Figure 4) for connecting of the vascular
graft to BYFix.
The BYFix is long term implantable device intended
to be used to rapidly and permanently connect any stan-
dard artificial vascular graft to any blood vessel which
has a diameter of more than 5 mm, for treatment of aortic
and peripheral aneurysms, arterial occlusions and blood
vessel traumas.
The full details of the BYFix device and the technical
bases of using it for creating anastomoses was described
in previous paper by B. Yoffe et al. [8]. The BYFix im-
planted device diameter was determined by artery meas-
urements, using measuring devices and by pre-operative
Figure 1. The BYFix device attached to different vascular
Figure 2. The BYFix device.
Copyright © 2011 SciRes. SS
Figure 3. The measurement device.
Figure 4. The inversion device.
2.4. The Surgical Procedure
The standard surgical approach was performed to expose
and prepare the affected vascular segment for grafting.
The incision was performed in the superficial femoral
artery, immediately above the occlusion with endarter-
ectomy, if needed. Vessel diameter was measured by
insertion of measuring device into the proximal direction
from smaller diameters to larger, up to visible deforma-
tion of the vessel wall without its tear. The proximal side
of the vascular graft was attached to the BYFix device
using the inversion device and the BYFix graft (vascular
graft with attached BYFix device) was inserted into the
proximal part of the vessel digitally or with a grasper in a
parallel direction to the vessel long axis, up to the fixa-
tion point (Figure 5). The proximal vascular clamp then
was moved from the proximal part of the vessel to the
vascular graft for testing the hermetic quality of the
proximal anastomosis.
The distal anastomosis was created by a standard pro-
cedure (manual suturing).
Throughout the procedure the duration of clamping
time and the time for creating each anastomosis were
recorded. Observational data regarding success of im-
planting BYFix device, blood loss and anastomosis effi-
cacy was documented.
2.5. Follow Up
The patients had been followed up with pre-discharge
evaluation that included: ABI measurement, Doppler test
of lower extremities, claudication distance and Duplex to
assess the position of implanted device and anastomosis
leakage, and then follow up visits at 1 week after hospital
discharge, at 1, 3, 6 and 12 months after surgery. The
Figure 5. The BYFix graft insertion into the femoral artery.
visits included routine physical examination, documenta-
tion of postoperative adverse events, postoperative im-
aging and Lab tests as needed.
3. Results
The 7 enrolled patients underwent the study procedure,
completed follow up period of 12 months, up to Decem-
ber 2010, and were included in the analysis. The study
population consists of 7 male, age 63.6 ± 9.2 years
(range 55 - 78 years), and weight 76 ± 7.9 kg (range 70 -
85 kg).
All patients had undergone the surgery using BYFix
device for common femoral artery or SFA occlusion.
Seven anastomoses (all proximal) were created using
BYFix anastomotic device. The distal anastomoses (n =
7) were created by manual suturing. The vascular grafts
used were made from PTFE.
The anastomoses by using BYFix anastomotic device
were successfully created in all patients. The duration of
anastomosis creation was significantly shorter by using
BYFix device, compared to conventional manual sutur-
ing, 5:10 ± 1:50 minutes compared to 33 ± 17:40 minutes
respectively. No serious adverse events related to BYFix
anastomotic device were observed during the surgical
procedure or recovery period at hospital.
During the 12 months follow up period, no complica-
tions or serious adverse events were observed according
to the monitoring follow up visits. Throughout the follow
up period, the imaging procedures revealed no evidence
of leakage from anastomosis, stenosis or displacement of
the BYFix.
4. Discussion
BYFix device is an innovative device, intended for cre-
ating suture-less vascular anastomosis. The device was
tested to be feasible and efficient in preclinical studies on
vascular samples, cadavers and animals. This clinical
Copyright © 2011 SciRes. SS
Copyright © 2011 SciRes. SS
study was designed and conducted to test the BYFix de-
vice in clinical practice, its feasibility in creating periph-
eral vascular anastomosis and the potential adverse
events or complications.
The study demonstrates the feasibility and safety of
BYFix device in creation of anastomoses in the arteries
of lower extremities. The BYFix device was demon-
strated to be useful in the repair of artery occlusion of
lower extremities.
In the current study the advantages of BYFix device
over sutured anastomosis were demonstrated in clinical
practice. The creation of anastomosis is simple and fast,
the anastomoses are standardized, thus the duration of
vascular clamping is shortened. These advantages would
be even more pronounced as vascular surgeons become
more familiar with the technique and gain experience in
using it. This technique as it eliminates the need for su-
turing, is of special value in the repair of technically dif-
ficult aneurysms and suitable for laparoscopic surgery. In
the current study both types of anastomoses sutured as
well as suture-less were created in each patient.
Throughout the follow up period, the imaging proce-
dures revealed no evidence of leakage from anastomosis,
displacement of the BYFix or restenosis.
5. Conclusions
In conclusion, the BYFix anastomotic device enables
safe and efficient anastomosis between arteries of lower
extremities to a conventional graft. It can be applied eas-
ily and significantly shorten the time, that needed for
creating anastomosis.
Although BYFix device and method is not less inva-
sive than the manual suturing method, it has the potential
to shorten the duration of the surgical procedure and to
be applied in laparoscopic surgery.
Controlled clinical trials are required to establish the
results, which have been achieved in this study.
6. References
[1] M. H. Criqui, J. O. Denenberg, R. D. Langer, et al., “The
Epidemiology of Peripheral Arterial Disease: Importance
of Identifying the Populationat Risk,” Vascular Medicine,
Vol. 2, No. 3, 1997, pp. 221-226.
[2] J. M. Murabito, R. B. D’Agostino, H. Silbershatz, et al.,
“Intermittent Claudication. A Risk Profile from the Fram-
ingham Heart Study,” Circulation, 1997, Vol. 96, pp. 44-
[3] R. A. Linsky, K. S. Korr and I. Sadiq, “Contemporary
Management of Peripheral Arterial Disease: A Review,”
Medicine and Health Rhode Island, Vol. 91, No. 10, 2008,
pp. 305-308.
[4] A. T. Hirsch, Z. J. Haskal, et al., “ACC/AHA Guidelines
for the Management of Patients with Peripheral Arterial
Disease (Lower Extremity, Renal Mesenteric, and Ab-
dominal Aortic): Executive Summary: A Collaborative
Report from the American Association for Vascular Sur-
gery/Society for Vascular Surgery, Society for Vascular
Medicine and Biology, Society of Interventional Radiol-
ogy and the ACC/AHA Task Force on Practice Guide-
lines (Writing Committee to Develop Guidelines for the
Management of Patients with Peripheral Arterial Dis-
ease,” Journal of the American College of Cardiology,
Vol. 47, No. 6, 2006, pp. 1239-1312.
[5] M. D. McDaniel and J. L. Cronenwett, “Basic Data Re-
lated to the Natural History of Intermittent Claudication,”
Annals of Vascular Surgery, Vol. 3, No. 3, 1989, pp. 273-
277. doi:10.1016/S0890-5096(07)60040-5
[6] A. M. Imparato, G. E. Kim, T. Davidson and J. G. Crow-
ley, “Intermittent Claudication: Its Natural Course,” Sur-
gery, Vol. 78, No. 6, 1975, pp. 795-799.
[7] N. N. Dagher and J. G. Modrall, “Pharmacotherapy be-
fore and after Revascularization: Anticoagulation, Anti-
platelet Agents, and Statins,” Seminars in Vascular Sur-
gery, Vol. 20, No. 1, 2007, pp. 10-14.
[8] B. Yoffe, et al., “Experimental Study of a Novel Suture-
Less Aortic Anastomotic Device,” European Journal of
Vascular and Endovascular Surgery, Vol. 34, No. 1,
2007, pp. 79-86. doi:10.1016/j.ejvs.2007.02.004